| Pre-prescription spectacle lens | | Pre-prescription spectacle lens | | Class I
|
| Prealbumin (transthyretin) IVD, calibrator | | Prealbumin (transthyretin) IVD, calibrator | | IVD General
|
| Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry | | Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry | | IVD General
|
| Preformed complete denture | | Preformed complete denture | |
|
| Preformed complete denture | | Preformed complete denture | | Class I
|
| Preformed complete denture | | Preformed complete denture | | Class IIa
|
| Preformed complete denture | | Preformed complete denture | | Class IIb
|
| Preformed dental crown, permanent | | Preformed dental crown, permanent | |
|
| Preformed dental crown, permanent | | Preformed dental crown, permanent | | Class I
|
| Preformed dental crown, permanent | | Preformed dental crown, permanent | | Class IIa
|
| Preformed dental crown, permanent | | Preformed dental crown, permanent | | Class IIb
|
| Preformed dental crown, temporary | | Preformed dental crown, temporary | |
|
| Preformed dental crown, temporary | | Preformed dental crown, temporary | | Class I
|
| Preformed dental crown, temporary | | Preformed dental crown, temporary | | Class IIa
|
| Preformed dental crown, temporary | | Preformed dental crown, temporary | | Class IIb
|
| Preformed vocal cord medialization implant | | Preformed vocal cord medialization implant | | Class IIb
|
| Pregabalin IVD, kit, immunochromatographic test (ICT), rapid | | Pregabalin IVD, kit, immunochromatographic test (ICT), rapid | | IVD General
|
| Pregnancy-associated plasma protein A (PAPP-A) IVD, calibrator | | Pregnancy-associated plasma protein A (PAPP-A) IVD, calibrator | | IVD Annex II List B
|
| Pregnancy-associated plasma protein A (PAPP-A) IVD, kit, fluorescence immunoassay | | Pregnancy-associated plasma protein A (PAPP-A) IVD, kit, fluorescence immunoassay | | IVD Annex II List B
|
| Pregnancy-associated plasma protein A (PAPP-A) IVD, reagent | | Pregnancy-associated plasma protein A (PAPP-A) IVD, reagent | | IVD Annex II List B
|
| Prescribed Orthopaedic Footwear | | Prescribed Orthopaedic Footwear | | Class I
|
| Prescribed Spectacles and contact lens kits | | Prescribed Spectacles and contact lens kits | |
|
| Prescribed Spectacles (Not Article 12) | | Prescribed Spectacles (Not Article 12) | | Class I
|
| Prescribed Spectacles | | Prescribed Spectacles | |
|
| Prescribed Spectacles | | Prescribed Spectacles | | Class I
|
| Prescription spectacle lens, custom-made | | Prescription spectacle lens, custom-made | |
|
| Prescription spectacle lens, custom-made | | Prescription spectacle lens, custom-made | | Class I
|
| Prescription spectacle lens, non-customized | | Prescription spectacle lens, non-customized | |
|
| Prescription spectacle lens, non-customized | | Prescription spectacle lens, non-customized | | Class I
|
| Prescription spectacles | | Prescription spectacles | |
|
| Prescription spectacles | | Prescription spectacles | | Class I
|
| Press-fit femoral stem prosthesis | | Press-fit femoral stem prosthesis | |
|
| Press-fit femoral stem prosthesis | | Press-fit femoral stem prosthesis | | Class III
|
| Press-fit hip femur prosthesis, modular | | Press-fit hip femur prosthesis, modular | |
|
| Press-fit hip femur prosthesis, modular | | Press-fit hip femur prosthesis, modular | | Class III
|
| Press-fit hip femur prosthesis, one-piece | | Press-fit hip femur prosthesis, one-piece | |
|
| Press-fit hip femur prosthesis, one-piece | | Press-fit hip femur prosthesis, one-piece | | Class IIb
|
| Press-fit hip femur prosthesis, one-piece | | Press-fit hip femur prosthesis, one-piece | | Class III
|
| Press-fit shoulder humeral stem prosthesis | | Press-fit shoulder humeral stem prosthesis | |
|
| Press-fit shoulder humeral stem prosthesis | | Press-fit shoulder humeral stem prosthesis | | Class IIb
|
| Press-fit shoulder humeral stem prosthesis | | Press-fit shoulder humeral stem prosthesis | | Class III
|
| Pressure-controlled intermittent coronary sinus occlusion system control unit | | Pressure-controlled intermittent coronary sinus occlusion system control unit | | Class IIb
|
| Pressure-controlled intermittent coronary sinus occlusion system | | Pressure-controlled intermittent coronary sinus occlusion system | | Class III
|
| Pressure-management bandage, silicone | | Pressure-management bandage, silicone | | Class I
|
| Pressure-management insole, custom-made | | Pressure-management insole, custom-made | |
|
| Pressure-management insole, custom-made | | Pressure-management insole, custom-made | | Class I
|
| Pressure-management insole, prefabricated | | Pressure-management insole, prefabricated | |
|
| Pressure-management insole, prefabricated | | Pressure-management insole, prefabricated | | Class I
|
| Pressure-management sock | | Pressure-management sock | | Class I
|
| Pressure algometer/aesthesiometer, mechanical | | Pressure algometer/aesthesiometer, mechanical | | Class I
|
| Pressure bandage, Hevea-latex, reusable | | Pressure bandage, Hevea-latex, reusable | | Class I
|
| Pressure bandage, Hevea-latex, single-use | | Pressure bandage, Hevea-latex, single-use | | Class I
|
| Pressure bandage, Hevea-latex, single-use, non-sterile | | Pressure bandage, Hevea-latex, single-use, non-sterile | | Class I
|
| Pressure bandage, non-latex, reusable | | Pressure bandage, non-latex, reusable | | Class I
|
| Pressure bandage, non-latex, single-use | | Pressure bandage, non-latex, single-use | | Class I
|
| Pressure monitor calibration weight | | Pressure monitor calibration weight | | Class I
|
| Pressure Relief Devices And Accessories | | Pressure Relief Devices And Accessories | | Class I
|
| Pressure relief valve, reusable | | Pressure relief valve, reusable | | Class IIb
|
| Pressure relief valve, single-use | | Pressure relief valve, single-use | | Class I
|
| Pressure relief valve, single-use | | Pressure relief valve, single-use | | Class IIa
|
| Pressure transducer dome, single-use | | Pressure transducer dome, single-use | | Class IIa
|
| Primary battery | | Primary battery | |
|
| Primary battery | | Primary battery | | Class IIb
|
| Prism Glasses | | Prism Glasses | | Class I
|
| Procalcitonin (PCT) IVD, calibrator | | Procalcitonin (PCT) IVD, calibrator | | IVD General
|
| Procalcitonin (PCT) IVD, control | | Procalcitonin (PCT) IVD, control | | IVD General
|
| Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay | | Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay | | IVD General
|
| Procalcitonin (PCT) IVD, kit, enzyme immunoassay (EIA) | | Procalcitonin (PCT) IVD, kit, enzyme immunoassay (EIA) | | IVD General
|
| Procalcitonin (PCT) IVD, kit, fluorescent immunoassay | | Procalcitonin (PCT) IVD, kit, fluorescent immunoassay | | IVD General
|
| Procalcitonin (PCT) IVD, kit, immunochromatographic test (ICT), rapid | | Procalcitonin (PCT) IVD, kit, immunochromatographic test (ICT), rapid | | IVD General
|
| Procedure Packs | | Procedure Packs | |
|
| Proctoscopes, Anascopes And Accessories | | Proctoscopes, Anascopes And Accessories | | Class I
|
| Proctoscope, reusable | | Proctoscope, reusable | | Class I
|
| Proctoscope, single-use | | Proctoscope, single-use | |
|
| Proctoscope, single-use | | Proctoscope, single-use | | Class I
|
| Proctoscope, single-use | | Proctoscope, single-use | | Class IIa
|
| Professional BPAP/high-flow respiratory unit | | Professional BPAP/high-flow respiratory unit | | Class IIb
|
| Professional examination gown, single-use | | Professional examination gown, single-use | | Class I
|
| Professional high-flow respiratory unit | | Professional high-flow respiratory unit | | Class IIa
|
| Profiling And Therapeutic Beds | | Profiling And Therapeutic Beds | | Class I
|
| Progastrin-releasing peptide (ProGRP) IVD, calibrator | | Progastrin-releasing peptide (ProGRP) IVD, calibrator | | IVD General
|
| Progastrin-releasing peptide (ProGRP) IVD, control | | Progastrin-releasing peptide (ProGRP) IVD, control | | IVD General
|
| Progastrin-releasing peptide (ProGRP) IVD, kit, chemiluminescent immunoassay | | Progastrin-releasing peptide (ProGRP) IVD, kit, chemiluminescent immunoassay | | IVD General
|
| Progesterone IVD, kit, enzyme immunoassay (EIA) | | Progesterone IVD, kit, enzyme immunoassay (EIA) | | IVD General
|
| Progesterone IVD, kit, radioimmunoassay | | Progesterone IVD, kit, radioimmunoassay | | IVD General
|
| Programmed death-ligand 1 (PD-L1) IVD, antibody | | Programmed death-ligand 1 (PD-L1) IVD, antibody | | IVD General
|
| Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry | | Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry | | IVD General
|
| Prolactin IVD, kit, enzyme immunoassay (EIA) | | Prolactin IVD, kit, enzyme immunoassay (EIA) | | IVD General
|
| Prolactin IVD, kit, radioimmunoassay | | Prolactin IVD, kit, radioimmunoassay | | IVD General
|
| Proliferating cell nuclear antigen (PCNA) IVD, antibody | | Proliferating cell nuclear antigen (PCNA) IVD, antibody | | IVD General
|
| Propoxyphene IVD, control | | Propoxyphene IVD, control | | IVD General
|
| Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid | | Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid | | IVD General
|
| Prostate-specific membrane antigen (PSMA) IVD, antibody | | Prostate-specific membrane antigen (PSMA) IVD, antibody | | IVD Annex II List B
|
| Prostate brachytherapy system applicator, manual | | Prostate brachytherapy system applicator, manual | |
|
| Prostate brachytherapy system applicator, manual | | Prostate brachytherapy system applicator, manual | | Class I
|
| Prostate brachytherapy system applicator, manual | | Prostate brachytherapy system applicator, manual | | Class IIa
|
| Prostate brachytherapy system applicator, remote-afterloading | | Prostate brachytherapy system applicator, remote-afterloading | |
|
| Prostate brachytherapy system applicator, remote-afterloading | | Prostate brachytherapy system applicator, remote-afterloading | | Class IIa
|
| Prostatic acid phosphatase (PAP) IVD, antibody | | Prostatic acid phosphatase (PAP) IVD, antibody | | IVD General
|
| Prostatic retraction implant | | Prostatic retraction implant | | Class IIb
|
| Protective Films (Varnish) | | Protective Films (Varnish) | | Class I
|
| Protective Powder | | Protective Powder | | Class I
|
| Protein C IVD, kit, fluorescent immunoassay | | Protein C IVD, kit, fluorescent immunoassay | | IVD General
|
| Protein gene product 9.5 (PGP9.5) IVD, antibody | | Protein gene product 9.5 (PGP9.5) IVD, antibody | | IVD General
|
| Protein kinase B IVD, antibody | | Protein kinase B IVD, antibody | | IVD General
|
| Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, control | | Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, control | | IVD General
|
| Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA) | | Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA) | | IVD General
|
| Prothrombin time (PT) IVD, control | | Prothrombin time (PT) IVD, control | | IVD General
|
| Prothrombin time (PT) IVD, kit, clotting | | Prothrombin time (PT) IVD, kit, clotting | | IVD General
|
| Prothrombin time (PT) IVD, kit, clotting, rapid | | Prothrombin time (PT) IVD, kit, clotting, rapid | | IVD Devices for Self-Testing
|
| Prothrombin time (PT) IVD, kit, clotting, rapid | | Prothrombin time (PT) IVD, kit, clotting, rapid | | IVD General
|
| Prothrombin time (PT) IVD, reagent | | Prothrombin time (PT) IVD, reagent | | IVD General
|
| Proton therapy system | | Proton therapy system | | Class IIb
|
| Protruding ear correction implant positioner trial | | Protruding ear correction implant positioner trial | | Class I
|
| Protruding ear correction implant | | Protruding ear correction implant | |
|
| Protruding ear correction implant | | Protruding ear correction implant | | Class IIb
|
| Proximal interphalangeal joint prosthesis, modular | | Proximal interphalangeal joint prosthesis, modular Conformity Assessment Certificate Expired | | Class IIb
|
| Proximal interphalangeal joint prosthesis, modular | | Proximal interphalangeal joint prosthesis, modular | | Class IIb
|
| Proximal interphalangeal joint prosthesis, one-piece | | Proximal interphalangeal joint prosthesis, one-piece | | Class IIb
|
| Psychiatric-therapy/physical-therapy transcutaneous electrical stimulation system | | Psychiatric-therapy/physical-therapy transcutaneous electrical stimulation system | | Class IIa
|
| Psychological assessment software | | Psychological assessment software | |
|
| Psychological assessment software | | Psychological assessment software | | Class I
|
| Ptosis sling | | Ptosis sling | | Class IIb
|
| Public face mask, single-use | | Public face mask, single-use | | Class I
|
| Pulmonary artery balloon catheter, standard | | Pulmonary artery balloon catheter, standard | | Class III
|
| Pulmonary artery balloon catheter, thermal dilution | | Pulmonary artery balloon catheter, thermal dilution | | Class III
|
| Pulmonary function analysis system, adult | | Pulmonary function analysis system, adult | | Class I
|
| Pulmonary function analysis system, adult | | Pulmonary function analysis system, adult | | Class IIa
|
| Pulmonary function testing filter/mouthpiece | | Pulmonary function testing filter/mouthpiece | | Class I
|
| Pulmonary function testing filter/mouthpiece | | Pulmonary function testing filter/mouthpiece | | Class IIa
|
| Pulmonary function testing kit | | Pulmonary function testing kit | |
|
| Pulmonary function testing kit | | Pulmonary function testing kit | | Class IIa
|
| Pulmonary function testing nasal mask | | Pulmonary function testing nasal mask | | Class I
|
| Pulmonary function valve | | Pulmonary function valve | | Class IIa
|
| Pulmonary heart valve bioprosthesis | | Pulmonary heart valve bioprosthesis | | Class III
|
| Pulmonary resuscitator, manual, reusable | | Pulmonary resuscitator, manual, reusable | | Class IIa
|
| Pulmonary resuscitator, manual, single-use | | Pulmonary resuscitator, manual, single-use | | Class IIa
|
| Pulmonary resuscitator, pneumatic, reusable | | Pulmonary resuscitator, pneumatic, reusable | | Class IIa
|
| Pulmonary resuscitator, pneumatic, reusable | | Pulmonary resuscitator, pneumatic, reusable | | Class IIb
|
| Pulmonary sound analysis system | | Pulmonary sound analysis system | | Class IIa
|
| Pulmonary transcatheter heart valve bioprosthesis | | Pulmonary transcatheter heart valve bioprosthesis | | Class III
|
| Pulse Co-oximeter probe, reusable | | Pulse Co-oximeter probe, reusable | | Class IIb
|
| Pulse Co-oximeter probe, single-use | | Pulse Co-oximeter probe, single-use | | Class IIb
|
| Pulse Co-oximeter | | Pulse Co-oximeter | | Class IIb
|
| Pulse oximeter probe, reusable | | Pulse oximeter probe, reusable | | Class I
|
| Pulse oximeter probe, reusable | | Pulse oximeter probe, reusable | | Class IIa
|
| Pulse oximeter probe, reusable | | Pulse oximeter probe, reusable | | Class IIb
|
| Pulse oximeter probe, single-use | | Pulse oximeter probe, single-use | | Class IIa
|
| Pulse oximeter probe, single-use | | Pulse oximeter probe, single-use | | Class IIb
|
| Pulse oximeter, battery-powered | | Pulse oximeter, battery-powered | |
|
| Pulse oximeter, battery-powered | | Pulse oximeter, battery-powered | | Class IIa
|
| Pulse oximeter, battery-powered | | Pulse oximeter, battery-powered | | Class IIb
|
| Pulse oximeter, line-powered | | Pulse oximeter, line-powered | | Class IIa
|
| Pulse oximeter, line-powered | | Pulse oximeter, line-powered | | Class IIb
|
| Pulse oximetry telemetric monitoring system | | Pulse oximetry telemetric monitoring system | | Class IIa
|
| Pulsed signal therapy system extremity coil | | Pulsed signal therapy system extremity coil | | Class IIa
|
| Pupillograph | | Pupillograph | | Class IIa
|
| Pure-tone audiometer | | Pure-tone audiometer | | Class I
|
| Pure-tone audiometer | | Pure-tone audiometer | | Class IIa
|
| Pure wool burn sheet | | Pure wool burn sheet | | Class IIb
|
| Pure wool neck/shoulder insulator | | Pure wool neck/shoulder insulator | | Class I
|
| Pure wool pillow | | Pure wool pillow | | Class IIa
|
| Pylorus clamp | | Pylorus clamp | | Class I
|
| Pyrrolidonyl arylamidase (PYR) microbial reagent IVD | | Pyrrolidonyl arylamidase (PYR) microbial reagent IVD | | IVD General
|
| Quadriceps board exerciser | | Quadriceps board exerciser | | Class I
|
| Quaternary ammonium compound device disinfectant/sterilant test strip | | Quaternary ammonium compound device disinfectant/sterilant test strip | | Class I
|
| Rabies virus antigen IVD, antibody | | Rabies virus antigen IVD, antibody | | IVD General
|
| Radial artery compression device | | Radial artery compression device | | Class I
|
| Radial artery compression device | | Radial artery compression device | | Class IIa
|
| Radial surgical retractor seal cap | | Radial surgical retractor seal cap | | Class IIa
|
| Radial surgical retractor | | Radial surgical retractor | | Class I
|
| Radial surgical retractor | | Radial surgical retractor | | Class IIa
|
| Radiation attenuating Hevea-latex surgical/procedural glove | | Radiation attenuating Hevea-latex surgical/procedural glove | | Class IIa
|
| Radiation attenuating polyisoprene surgical/procedural glove | | Radiation attenuating polyisoprene surgical/procedural glove | | Class IIa
|
| Radiation shielding apron | | Radiation shielding apron | | Class I
|
| Radiation shielding collar | | Radiation shielding collar | | Class I
|
| Radiation shielding container, general-purpose | | Radiation shielding container, general-purpose | |
|
| Radiation shielding curtain | | Radiation shielding curtain | | Class I
|
| Radiation shielding panel, portable/mobile | | Radiation shielding panel, portable/mobile | | Class I
|
| Radiation therapy beam block material | | Radiation therapy beam block material | |
|
| Radiation therapy bolus, reusable | | Radiation therapy bolus, reusable | | Class I
|
| Radiation therapy digital imager | | Radiation therapy digital imager | | Class IIb
|
| Radiation therapy invasive marker lesion localization system | | Radiation therapy invasive marker lesion localization system | | Class IIb
|
| Radiation therapy software | | Radiation therapy software | | Class IIb
|
| Radiation therapy treatment planning positioning kit | | Radiation therapy treatment planning positioning kit | | Class I
|
| Radiation therapy treatment record/verify system | | Radiation therapy treatment record/verify system | | Class IIb
|
| Radiation/mechanical corneal shield, reusable | | Radiation/mechanical corneal shield, reusable | | Class I
|
| Radiation/mechanical corneal shield, single-use | | Radiation/mechanical corneal shield, single-use | | Class I
|
| Radio-frequency ablation system generator | | Radio-frequency ablation system generator | | Class I
|
| Radio-frequency ablation system generator | | Radio-frequency ablation system generator | | Class IIb
|
| Radio-frequency ablation system probe cannula, reusable | | Radio-frequency ablation system probe cannula, reusable | | Class III
|
| Radio-frequency ablation system probe cannula, single-use | | Radio-frequency ablation system probe cannula, single-use | | Class IIa
|
| Radio-frequency ablation system probe cannula, single-use | | Radio-frequency ablation system probe cannula, single-use | | Class IIb
|
| Radio-frequency ablation system probe cannula, single-use | | Radio-frequency ablation system probe cannula, single-use | | Class III
|
| Radio-frequency ablation system probe, reusable | | Radio-frequency ablation system probe, reusable Conformity Assessment Certificate Expired | | Class IIb
|
| Radio-frequency ablation system probe, reusable | | Radio-frequency ablation system probe, reusable | | Class IIb
|
| Radio-frequency ablation system | | Radio-frequency ablation system | | Class I
|
| Radio-frequency ablation system | | Radio-frequency ablation system | | Class IIa
|
| Radio-frequency ablation system | | Radio-frequency ablation system | | Class IIb
|
| Radio-frequency ablation system | | Radio-frequency ablation system | | Class III
|