| Bench-top keratometer | | Bench-top keratometer | | Class I Devices |
| Beverage thickness assessment tool | | Beverage thickness assessment tool | | Class I
|
| Bib | | Bib | | Class I Devices |
| Bib/apron, adult, reusable | | Bib/apron, adult, reusable | | Class I Devices |
| Bib/apron, adult, reusable | | Bib/apron, adult, reusable | | Class I Devices |
| Bib/apron, adult, single-use | | Bib/apron, adult, single-use | | Class I Devices |
| Bib/apron, adult, single-use | | Bib/apron, adult, single-use | | Class I Devices |
| Bicompartmental knee prosthesis | | Bicompartmental knee prosthesis | |
|
| Bidirectional-anaesthesia breathing circuit | | Bidirectional-anaesthesia breathing circuit | | Class I
|
| Binocular vision test unit | | Binocular vision test unit | | Class I
|
| Bio-energy system passive sensor | | Bio-energy system passive sensor | | Class I
|
| bioDensity | | bioDensity | | Class I
|
| Biofeedback system application software | | Biofeedback system application software | | Class I
|
| Biofeedback system | | Biofeedback system | | Class I Devices |
| Biolectracer Device | | Biolectracer Device | | Class I
|
| Biological sterilization indicator reader | | Biological sterilization indicator reader | | Class I Devices |
| Biological sterilization indicator | | Biological sterilization indicator | | Class I Devices |
| Biological sterilization indicator | | Biological sterilization indicator | | Class I Devices |
| Biomechanical function analysis system force-testing portable | | Biomechanical function analysis system force-testing portable | | Class I
|
| Biomechanical function analysis system motion-tracking | | Biomechanical function analysis system motion-tracking | |
|
| Biomechanical function analysis system motion-tracking | | Biomechanical function analysis system motion-tracking | | Class I
|
| Biomechanical function analysis/interactive rehabilitation system | | Biomechanical function analysis/interactive rehabilitation system | | Class I
|
| Biomechanical function analysis/rehabilitation software | | Biomechanical function analysis/rehabilitation software | |
|
| Biomechanical function analysis/rehabilitation software | | Biomechanical function analysis/rehabilitation software | | Class I
|
| Biopsy drill bit | | Biopsy drill bit | | Class I
|
| Biopsy punch reusable | | Biopsy punch reusable | | Class I
|
| Bipolar Cables | | Bipolar Cables | | Class I
|
| Bipolar partial shoulder prosthesis | | Bipolar partial shoulder prosthesis | |
|
| Birth Mirror | | Birth Mirror | | Class I
|
| Birthing cushion | | Birthing cushion | | Class I
|
| Birthing/delivery kit | | Birthing/delivery kit | |
|
| Bite registration rim wax plate | | Bite registration rim wax plate | |
|
| Bite registration rim wax plate | | Bite registration rim wax plate | | Class I
|
| Bite registration rim wax | | Bite registration rim wax | |
|
| Bite registration rim wax | | Bite registration rim wax | | Class I
|
| Bite registration rim | | Bite registration rim | |
|
| Bite relief pad | | Bite relief pad | |
|
| Bite Wing Loops (X-Ray Film Positioning) | | Bite Wing Loops (X-Ray Film Positioning) | | Class I
|
| Bladder neck spreader | | Bladder neck spreader | | Class I
|
| Blade endosteal dental implant one-piece | | Blade endosteal dental implant one-piece | |
|
| Blade endosteal dental implant two-piece | | Blade endosteal dental implant two-piece | |
|
| Blade, | | Blade, | | Class I Devices |
| Blakoe Ring | | Blakoe Ring | | Class I
|
| Blanket, | | Blanket, | | Class I Devices |
| Blood collection tube holder, reusable | | Blood collection tube holder, reusable | | Class I Devices |
| Blood collection tube holder, single-use | | Blood collection tube holder, single-use | | Class I Devices |
| Blood collection tube holder/needle | | Blood collection tube holder/needle | | Class I
|
| Blood donor set quad-pack | | Blood donor set quad-pack | |
|
| Blood lancet reusable | | Blood lancet reusable | | Class I
|
| Blood lancet, single-use | | Blood lancet, single-use | | Products Covered By Article 12 |
| Blood pressure cuff reusable | | Blood pressure cuff reusable | | Class I
|
| Blood pressure cuff, reusable | | Blood pressure cuff, reusable | | Class I Devices |
| Blood pressure cuff, single-use | | Blood pressure cuff, single-use | | Class I Devices |
| Blood Pressure Monitors | | Blood Pressure Monitors | | Class I
|
| Blood pressure transducer holder | | Blood pressure transducer holder | | Class I
|
| Blood Sampling Devices (Re-Usable) | | Blood Sampling Devices (Re-Usable) | | Class I
|
| Blood Specimen Collection Kits | | Blood Specimen Collection Kits | |
|
| Blood / plasma storage refrigerators / freezers | | Blood / plasma storage refrigerators / freezers | | Class I
|
| Blood/body fluid solidifier | | Blood/body fluid solidifier | | Class I
|
| Body And Cranio-Maxillofacial Contouring Implants | | Body And Cranio-Maxillofacial Contouring Implants | | Class I
|
| Body aspiration needle reusable | | Body aspiration needle reusable | | Class I
|
| Body elastic exerciser | | Body elastic exerciser | | Class I Devices |
| Body elastic exerciser | | Body elastic exerciser | |
|
| Body elastic exerciser | | Body elastic exerciser | | Class I
|
| Body femoral/tibial extension stem coated | | Body femoral/tibial extension stem coated | |
|
| Body femoral/tibial extension stem uncoated | | Body femoral/tibial extension stem uncoated | |
|
| Bonded dental bridge | | Bonded dental bridge | |
|
| Bonded dental bridge | | Bonded dental bridge | | Class I
|
| Bone-nailing compression screw | | Bone-nailing compression screw | | Class I
|
| Bone-nailing spacer | | Bone-nailing spacer | |
|
| Bone-resection orthopaedic reamer reusable | | Bone-resection orthopaedic reamer reusable | |
|
| Bone-resection orthopaedic reamer reusable | | Bone-resection orthopaedic reamer reusable | | Class I
|
| Bone-resection orthopaedic reamer single-use | | Bone-resection orthopaedic reamer single-use | |
|
| Bone approximation clamp | | Bone approximation clamp | |
|
| Bone approximation clamp | | Bone approximation clamp | | Class I
|
| Bone awl | | Bone awl | | Class I
|
| Bone clamp traction bar | | Bone clamp traction bar | |
|
| Bone curette reusable | | Bone curette reusable | | Class I
|
| Bone cutter | | Bone cutter | |
|
| Bone cutter | | Bone cutter | | Class I
|
| Bone cutting forceps | | Bone cutting forceps | | Class I
|
| Bone distraction forceps | | Bone distraction forceps | | Class I
|
| Bone file | | Bone file | | Class I
|
| Bone file/rasp manual | | Bone file/rasp manual | |
|
| Bone file/rasp manual | | Bone file/rasp manual | | Class I
|
| Bone fixation plate pliers | | Bone fixation plate pliers | | Class I
|
| Bone graft delivery kit | | Bone graft delivery kit | |
|
| Bone holding forceps | | Bone holding forceps | | Class I
|
| Bone hook | | Bone hook | | Class I
|
| Bone lever/elevator | | Bone lever/elevator | | Class I
|
| Bone marrow biopsy needle reprocessed | | Bone marrow biopsy needle reprocessed | | Class I
|
| Bone matrix implant composite | | Bone matrix implant composite | |
|
| Bone matrix implant synthetic antimicrobial | | Bone matrix implant synthetic antimicrobial | |
|
| Bone matrix implant synthetic | | Bone matrix implant synthetic | |
|
| Bone matrix implant, synthetic | | Bone matrix implant, synthetic | | Class I Devices |
| Bone nail driver | | Bone nail driver | | Class I
|
| Bone nail end-cap sterile | | Bone nail end-cap sterile | |
|
| Bone nail guidewire reusable | | Bone nail guidewire reusable | |
|
| Bone nail guidewire reusable | | Bone nail guidewire reusable | | Class I
|
| Bone punch reusable | | Bone punch reusable | | Class I
|
| Bone raspatory | | Bone raspatory | | Class I
|
| Bone screw, non-biodegradable | | Bone screw, non-biodegradable | | Class I Devices |
| Bone skid | | Bone skid | | Class I
|
| Bone staple | | Bone staple | | Class I Devices |
| Bone tap reusable | | Bone tap reusable | | Class I
|
| Bone tap single-use non-sterile | | Bone tap single-use non-sterile | |
|
| Bone tap single-use non-sterile | | Bone tap single-use non-sterile | | Class I
|
| Bone tap single-use sterile | | Bone tap single-use sterile | |
|
| Bone trephine | | Bone trephine | |
|
| Bone trephine | | Bone trephine | | Class I
|
| Brachytherapy system remote afterloading source transfer tube | | Brachytherapy system remote afterloading source transfer tube | | Products Covered By Article 12 |
| Brain knife | | Brain knife | | Class I
|
| Brain spatula | | Brain spatula | | Class I
|
| Breast prosthesis external | | Breast prosthesis external | |
|
| Breathing circuit bag single-use | | Breathing circuit bag single-use | |
|
| Breathing circuit bag single-use | | Breathing circuit bag single-use | | Class I
|
| Breathing circuit condensate trap single-use | | Breathing circuit condensate trap single-use | | Class I
|
| Breathing circuit condensate trap, reusable | | Breathing circuit condensate trap, reusable | | Class I Devices |
| Breathing circuit multi-parameter sensor | | Breathing circuit multi-parameter sensor | | Class I Devices |
| Breathing circuit tube | | Breathing circuit tube | | Class I Devices |
| Breathing mouthpiece reusable | | Breathing mouthpiece reusable | |
|
| Breathing mouthpiece single-use | | Breathing mouthpiece single-use | | Class I
|
| Breathing mouthpiece, single-use | | Breathing mouthpiece, single-use | | Class I Devices |
| Bronchoscopic aspiration tube rigid | | Bronchoscopic aspiration tube rigid | | Class I
|
| Brush, cleaning, denture | | Brush, cleaning, denture | | Class I Devices |
| Brush, surgical scrub | | Brush, surgical scrub | | Class I Devices |
| BSI Basic Stand | | BSI Basic Stand | | Class I
|
| Bunion shield | | Bunion shield | | Class I
|
| Bunsen burner | | Bunsen burner | |
|
| Bur cleaning brush | | Bur cleaning brush | | Class I Devices |
| Burns Assessment | | Burns Assessment | | Class I
|
| C10 | | Image Storage And Retrieval System | | Class I Devices |
| C10 | | Image Storage And Retrieval System | | Products Covered By Article 12 |
| C10 | | Image Storage And Retrieval System | | Class I Devices |
| C11 | | Laryngoscopes/Otoscopes And Accessories | | Class I Devices |
| C11 | | Laryngoscopes/Otoscopes And Accessories | | Products Covered By Article 12 |
| C11 | | Laryngoscopes/Otoscopes And Accessories | | Class I Devices |
| C12 | | X-Ray Cassettes, Cassette Holders, Image Enhancers And Intensifying Screens | | Class I Devices |
| C12 | | X-Ray Cassettes, Cassette Holders, Image Enhancers And Intensifying Screens | | Class I Devices |
| C13 | | Radiographic Film Processing Chemicals | | Class I Devices |
| C14 | | X-Ray Film Illuminators | | Class I Devices |
| C14 | | X-Ray Film Illuminators | | Class I Devices |
| C15 | | Sampling And Cell Collection Devices (Patient Contact - Not IVDDs) | | Class I Devices |
| C15 | | Sampling And Cell Collection Devices (Patient Contact - Not IVDDs) | | Custom Made Devices |
| C15 | | Sampling And Cell Collection Devices (Patient Contact - Not IVDDs) | | Class I Devices |
| C1 | | Conductive Gels | | Class I Devices |
| C1 | | Conductive Gels | | Class I Devices |
| C2 | | Electrodes/Transducers And Accessories | | Class I Devices |
| C2 | | Electrodes/Transducers And Accessories | | Products Covered By Article 12 |
| C2 | | Electrodes/Transducers And Accessories | | Class I Devices |
| C2 | | Non-Invasive Electrodes/Transducers And Accessories | | Class I Devices |
| C3 | | Peak Flow Meters | | Class I Devices |
| C3 | | Peak Flow Meters | | Class I Devices |
| C4 | | Sphygmomanometers And Accessories | | Class I Devices |
| C4 | | Sphygmomanometers And Accessories | | Class I Devices |
| C5 | | Stethoscopes | | Class I Devices |
| C5 | | Stethoscopes | | Class I Devices |
| c6 | | Thermometers (Clinical) | | Class I Devices |
| C6 | | Thermometers (Clinical) | | Class I Devices |
| C7 | | Examination/Procedure Gloves | | Class I Devices |
| C7 | | Examination/Procedure Gloves | | Class I Devices |
| C8 | | Blood Sampling Devices (Re-Usable) | | Class I Devices |
| C8 | | Blood Sampling Devices (Re-Usable) | | Class I Devices |
| c9 | | Endoscopes/Endoscopic Instruments And Accessories | | Class I Devices |
| C9 | | Endoscopes/Endoscopic Instruments And Accessories | | Products Covered By Article 12 |
| C9 | | Endoscopes/Endoscopic Instruments And Accessories | | Class I Devices |
| Cabinet, instrument | | Cabinet, instrument | | Class I Devices |
| Cabinet, | | Cabinet, | | Class I Devices |
| Cable/lead/sensor/probe cover non-sterile | | Cable/lead/sensor/probe cover non-sterile | | Class I
|
| Cable/lead/sensor/probe cover sterile | | Cable/lead/sensor/probe cover sterile | | Class I
|
| Cable/lead/sensor/probe cover, non-sterile | | Cable/lead/sensor/probe cover, non-sterile | | Class I Devices |
| CAD/CAM software | | CAD/CAM software | | Class I Devices |
| CAD/CAM software | | CAD/CAM software | |
|
| Calculator programmable | | Calculator programmable | |
|
| Callous file/rasp reusable | | Callous file/rasp reusable | | Class I
|
| Camera application software | | Camera application software | | Class I
|
| Camera cover, single-use | | Camera cover, single-use | | Class I Devices |
| Cannulae (Reusable) | | Cannulae (Reusable) | | Class I
|
| Cannulated surgical drill bit reusable | | Cannulated surgical drill bit reusable | |
|
| Cannulated surgical drill bit reusable | | Cannulated surgical drill bit reusable | | Class I
|
| Cannulated surgical drill guiding pin | | Cannulated surgical drill guiding pin | |
|
| CAPHOSOL - Mouth Rinse | | CAPHOSOL - Mouth Rinse | | Class I
|
| CAPHOSOL Dispersible - Mouth Rinse | | CAPHOSOL Dispersible - Mouth Rinse | | Class I
|
| Capsular tension ring inserter | | Capsular tension ring inserter | | Class I
|
| Cap, head, | | Cap, head, | | Class I Devices |
| Carbide dental bur reusable | | Carbide dental bur reusable | |
|
| Carbide dental bur reusable | | Carbide dental bur reusable | | Class I
|
| Carboxymethylcellulose sodium denture adhesive | | Carboxymethylcellulose sodium denture adhesive | |
|
| Carboxymethylcellulose sodium/cationic polyacrylamide polymer denture adhesive | | Carboxymethylcellulose sodium/cationic polyacrylamide polymer denture adhesive | | Class I
|
| Cardiac resuscitator manual | | Cardiac resuscitator manual | | Class I
|
| Cardiology information system application software | | Cardiology information system application software | | Class I Devices |
| Cardiopulmonary bypass system centrifugal pump | | Cardiopulmonary bypass system centrifugal pump | |
|
| Cardiopulmonary resuscitation kit reusable | | Cardiopulmonary resuscitation kit reusable | | Class I
|
| Cardiopulmonary resuscitation mask reusable | | Cardiopulmonary resuscitation mask reusable | | Class I
|
| Cardiopulmonary resuscitation mouthpiece/cover | | Cardiopulmonary resuscitation mouthpiece/cover | | Class I
|
| Cardiothoracic surgical procedure kit non-medicated reusable | | Cardiothoracic surgical procedure kit non-medicated reusable | |
|
| Carpal tunnel release instrument | | Carpal tunnel release instrument | | Class I
|
| Cartilage knife | | Cartilage knife | | Class I
|
| Cart, instrument | | Cart, instrument | | Class I Devices |
| Cast breaker | | Cast breaker | | Class I
|