Manufacturer's Devices - Smith & Nephew Inc. Endoscopy Division

Address:




150 Minuteman Road



Andover

Massachusetts 01810

United States


Authorised Representative/ UK Responsible Person
Name: T.J.Smith and Nephew Limited
Address:

101 Hessle Road



Hull

HU3 2BN

England United Kingdom




Code/Term Type
Tendon/ligament bone anchor non-bioabsorbableTendon/ligament bone anchor non-bioabsorbableClass III
Percutaneous radio-frequency ablation system generatorPercutaneous radio-frequency ablation system generatorClass IIb
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass IIb
Surgical power tool adaptorSurgical power tool adaptorClass IIb
Open-surgery electrosurgical handpiece/electrode bipolar single-useOpen-surgery electrosurgical handpiece/electrode bipolar single-useClass IIb
Bone trephineBone trephineClass IIa
Bone awl reusableBone awl reusableClass IIa
StopcockStopcockClass IIa
Orthopaedic surgical procedure kit non-medicated single-useOrthopaedic surgical procedure kit non-medicated single-useClass IIa
Orthopaedic bur single-useOrthopaedic bur single-useClass IIa
Scalpel single-useScalpel single-useClass IIa
Suturing unit single-useSuturing unit single-useClass IIa
Suturing needle single-useSuturing needle single-useClass IIa
Ligament reconstruction instrument set single-useLigament reconstruction instrument set single-useClass IIb
Orthopaedic bone washer sterileOrthopaedic bone washer sterileClass IIb
Suturing unit single-useSuturing unit single-useClass IIb
Soft-tissue/mesh anchor bioabsorbableSoft-tissue/mesh anchor bioabsorbableClass III
Cartilage biomatrix implant animal-derivedCartilage biomatrix implant animal-derivedClass III
Extra-gynaecological surgical mesh collagen bioabsorbableExtra-gynaecological surgical mesh collagen bioabsorbableClass III
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass IIb
Orthopaedic bone screw non-bioabsorbable sterileOrthopaedic bone screw non-bioabsorbable sterileClass IIb
Tendon/ligament bone anchor bioabsorbableTendon/ligament bone anchor bioabsorbableClass III
Tendon/ligament bone anchor non-bioabsorbableTendon/ligament bone anchor non-bioabsorbableClass IIb
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIa
Arthroscopic access cannula single-useArthroscopic access cannula single-useClass IIa
Bone nail guidewire reusableBone nail guidewire reusableClass IIa
Surgical irrigation tubing set single-useSurgical irrigation tubing set single-useClass IIa
Arthroscopic surgical procedure kit non-medicated single-useArthroscopic surgical procedure kit non-medicated single-useClass IIa
Fluted surgical drill bit single-useFluted surgical drill bit single-useClass IIa
Rigid arthroscope reusableRigid arthroscope reusableClass IIa
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Bone file/rasp manual reusableBone file/rasp manual reusableClass IIa
Arthroscopic irrigation/insufflation systemArthroscopic irrigation/insufflation systemClass IIa
Arthroscopic shaver system electrically-poweredArthroscopic shaver system electrically-poweredClass IIa
Foot-switch electricalFoot-switch electricalClass IIa
Suture knot pusher single-useSuture knot pusher single-useClass IIa
Arthroscopic access cannula reusableArthroscopic access cannula reusableClass IIa
Arthroscopic shaver system blade single-useArthroscopic shaver system blade single-useClass IIa
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIa
Rigid arthroscope reusableRigid arthroscope reusableClass IIa
Rigid optical laparoscopeRigid optical laparoscopeClass IIa
Surgical power tool system control unit line-poweredSurgical power tool system control unit line-poweredClass IIa
Surgical saw blade reciprocating single-useSurgical saw blade reciprocating single-useClass IIa
Endoscopic light source adaptorEndoscopic light source adaptorClass IIa
Bone nail guidewire reusableBone nail guidewire reusableClass IIa
Gastro-urological guidewire single-useGastro-urological guidewire single-useClass IIa
Orthopaedic instrument surgical connectorOrthopaedic instrument surgical connectorClass IIa
Ligation clip synthetic polymer non-bioabsorbableLigation clip synthetic polymer non-bioabsorbableClass IIb
Bone tunnel plug cannulatedBone tunnel plug cannulatedClass IIa
Arthroscopic access cannula seal single-useArthroscopic access cannula seal single-useClass IIa
Suture cutter single-useSuture cutter single-useClass IIa
Polyolefin suture multifilamentPolyolefin suture multifilamentClass IIb
Leg procedure positionerLeg procedure positionerClass I
Instrument tray reusableInstrument tray reusableClass I
Noninvasive device battery chargerNoninvasive device battery chargerClass I
Surgical/medical face mask single-useSurgical/medical face mask single-useClass I
Fibreoptic light cableFibreoptic light cableClass I
Rigid endoscope obturatorRigid endoscope obturatorClass I
Endoscope video cameraEndoscope video cameraClass I
Foot-switch electricalFoot-switch electricalClass I
Rechargeable battery packRechargeable battery packClass I
Arm procedure positioner reusableArm procedure positioner reusableClass I
Medical table clampMedical table clampClass I
Infusion controller line-poweredInfusion controller line-poweredClass I
Tendon/ligament graft preparation station baseTendon/ligament graft preparation station baseClass I
Eye splash shield single-useEye splash shield single-useClass I
Arthroscopic obturatorArthroscopic obturatorClass I
Upper-limb traction wrap/trap single-use sterileUpper-limb traction wrap/trap single-use sterileClass I
Infant whole-body immobilizer single-useInfant whole-body immobilizer single-useClass I
Arthroscopic sleeve-seal connectorArthroscopic sleeve-seal connectorClass I
Surgical soft-tissue manipulation forceps alligator reusableSurgical soft-tissue manipulation forceps alligator reusableClass I
Surgical soft-tissue manipulation forceps scissors-like reusableSurgical soft-tissue manipulation forceps scissors-like reusableClass I
Surgical traction tensiometer mechanicalSurgical traction tensiometer mechanicalClass I
Orthopaedic instrument extractorOrthopaedic instrument extractorClass I
Rigid endoscope telescopeRigid endoscope telescopeClass I
Orthopaedic operating table electrohydraulicOrthopaedic operating table electrohydraulicClass I
Leg procedure positionerLeg procedure positionerClass I
Tendon/ligament graft preparation stationTendon/ligament graft preparation stationClass I
Electrical mains power cableElectrical mains power cableClass I
Tendon/ligament graft preparation station baseTendon/ligament graft preparation station baseClass I
Tendon/ligament graft preparation station postTendon/ligament graft preparation station postClass I
Freestanding patient positioner reusableFreestanding patient positioner reusableClass I
Arthroscopic access cannula reusableArthroscopic access cannula reusableClass I
Operating table torso positionerOperating table torso positionerClass I
Operating table torso positionerOperating table torso positionerClass I
Orthopaedic knee/leg holder linerOrthopaedic knee/leg holder linerClass I
Orthopaedic knee/leg holder linerOrthopaedic knee/leg holder linerClass I
Hand traction plateHand traction plateClass I
Surgical finger guardSurgical finger guardClass I
Manual orthopaedic bender reusableManual orthopaedic bender reusableClass I
Limb/torso/head restraint single-useLimb/torso/head restraint single-useClass I
Orthopaedic graft tensioner reusableOrthopaedic graft tensioner reusableClass I
Ligament graft sizer noninvasiveLigament graft sizer noninvasiveClass I
Anaesthesia face mask single-useAnaesthesia face mask single-useClass I
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass I
Surgical instrument/implant depth limiterSurgical instrument/implant depth limiterClass I
Orthopaedic surgical distractor externalOrthopaedic surgical distractor externalClass I
Leg procedure positionerLeg procedure positionerClass I
Orthopaedic chiselOrthopaedic chiselClass I
Orthopaedic knifeOrthopaedic knifeClass I
Orthopaedic joint/limb rongeurOrthopaedic joint/limb rongeurClass I
Surgical tamp reusableSurgical tamp reusableClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Surgical instrument guard reusableSurgical instrument guard reusableClass I
Bone lever/elevator reusableBone lever/elevator reusableClass I
Surgical gougeSurgical gougeClass I
Surgical drill guide reusableSurgical drill guide reusableClass I
Endoscopic light source unit line-poweredEndoscopic light source unit line-poweredClass I
Tendon stripperTendon stripperClass I
Surgical depth gauge reusableSurgical depth gauge reusableClass I
Surgical malletSurgical malletClass I
Open-surgery dissectorOpen-surgery dissectorClass I
Scalpel handle reusableScalpel handle reusableClass I
Medical equipment drape single-useMedical equipment drape single-useClass I
Orthopaedic osteotomeOrthopaedic osteotomeClass I
Surgical towelSurgical towelClass I
Bone awl reusableBone awl reusableClass I
Suture cutter reusableSuture cutter reusableClass I
Bone tap reusableBone tap reusableClass I
Endoscopic video image processing unitEndoscopic video image processing unitClass I
Bone curette reusableBone curette reusableClass I
Bone file/rasp manual reusableBone file/rasp manual reusableClass I
Rigid endoscope obturatorRigid endoscope obturatorClass I
Bone tunnel plug non-cannulatedBone tunnel plug non-cannulatedClass I
Suture knot pusher reusableSuture knot pusher reusableClass I
Hand-held surgical retractor reusableHand-held surgical retractor reusableClass I
Ligament reconstruction instrument set reusableLigament reconstruction instrument set reusableClass I
Orthopaedic trocar blade reusableOrthopaedic trocar blade reusableClass I
Orthopaedic instrument surgical connectorOrthopaedic instrument surgical connectorClass I
Orthopaedic implant aiming armOrthopaedic implant aiming armClass I
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass I
Orthopaedic implantation sleeve reusableOrthopaedic implantation sleeve reusableClass I
Orthopaedic implant/instrument adaptor reusableOrthopaedic implant/instrument adaptor reusableClass I
Ligament graft sizer noninvasiveLigament graft sizer noninvasiveClass I
Limb/torso/head restraint single-useLimb/torso/head restraint single-useClass I
Arthroscopic probeArthroscopic probeClass I
Endoscope video cameraEndoscope video cameraClass I
Arm procedure positioner reusableArm procedure positioner reusableClass I
Medical table clampMedical table clampClass I
Suturing unit reusableSuturing unit reusableClass I
Cartilage knifeCartilage knifeClass I
General-purpose surgical scissors reusableGeneral-purpose surgical scissors reusableClass I
General external orthopaedic fixation system implantation kit reusableGeneral external orthopaedic fixation system implantation kit reusableClass I
General internal orthopaedic fixation system implantation kitGeneral internal orthopaedic fixation system implantation kitClass I
Surgical instrument/implant depth limiterSurgical instrument/implant depth limiterClass I
Arthroscopic surgical procedure kit non-medicated reusableArthroscopic surgical procedure kit non-medicated reusableClass I
Ligament reconstruction instrument set reusableLigament reconstruction instrument set reusable
Shoe coverShoe coverClass I
Arthroscopic surgical procedure kit non-medicated single-useArthroscopic surgical procedure kit non-medicated single-useClass IIb
Arthroscopic obturatorArthroscopic obturatorClass I
Operating room audiovisual data/device management system application softwareOperating room audiovisual data/device management system application softwareClass I
Orthopaedic bone screw bioabsorbableOrthopaedic bone screw bioabsorbableClass III
Tendon/ligament bone anchor bioabsorbableTendon/ligament bone anchor bioabsorbableClass III
Orthopaedic bone screw bioabsorbableOrthopaedic bone screw bioabsorbableClass III
Meniscus knifeMeniscus knifeClass I
Bone holding forcepsBone holding forcepsClass I