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
Soft-tissue/mesh anchor bioabsorbableSoft-tissue/mesh anchor bioabsorbableClass IIb
Extra-gynaecological surgical mesh collagen bioabsorbableExtra-gynaecological surgical mesh collagen bioabsorbableClass III
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass III
Orthopaedic bone screw non-bioabsorbable sterileOrthopaedic bone screw non-bioabsorbable sterileClass IIb
Tendon/ligament bone anchor bioabsorbableTendon/ligament bone anchor bioabsorbableClass IIb
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass III
Arthroscopic access cannula single-useArthroscopic access cannula single-useClass IIb
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
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
Suture knot pusher single-useSuture knot pusher single-useClass IIa
Arthroscopic access cannula reusableArthroscopic access cannula reusableClass IIa
Rigid optical laparoscopeRigid optical laparoscopeClass IIa
Surgical saw blade reciprocating single-useSurgical saw blade reciprocating single-useClass IIa
Endoscopic light source adaptorEndoscopic light source adaptorClass 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 IIa
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/fluoropolymer suture multifilamentPolyolefin/fluoropolymer suture multifilamentClass IIa
Leg procedure positionerLeg procedure positionerClass IIa
Noninvasive device battery chargerNoninvasive device battery chargerClass IIb
Surgical/medical face mask single-useSurgical/medical face mask single-useClass IIa
Fibreoptic light cableFibreoptic light cableClass IIa
Rigid endoscope obturatorRigid endoscope obturatorClass IIa
Endoscope video cameraEndoscope video cameraClass IIb
Foot-switch electricalFoot-switch electricalClass I
Portable/mobile rechargeable battery packPortable/mobile rechargeable battery packClass I
Arm procedure positioner reusableArm procedure positioner reusableClass I
Medical table clampMedical table clampClass I
Electronic gravity infusion controllerElectronic gravity infusion controllerClass 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
Tendon/ligament graft preparation stationTendon/ligament graft preparation stationClass I
Electrical mains power cableElectrical mains power cableClass I
Tendon/ligament graft preparation station postTendon/ligament graft preparation station postClass I
Freestanding patient positioner reusableFreestanding patient positioner reusableClass I
Operating table torso positionerOperating table torso positionerClass 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
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
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 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 implant aiming armOrthopaedic implant aiming armClass I
Orthopaedic implantation sleeve reusableOrthopaedic implantation sleeve reusableClass I
Orthopaedic implant-instrument extension adaptor reusableOrthopaedic implant-instrument extension adaptor reusableClass I
Endoscopic surgical probeEndoscopic surgical probeClass 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
Arthroscopic surgical procedure kit non-medicated reusableArthroscopic surgical procedure kit non-medicated reusableClass I
Shoe coverShoe coverClass 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 I
Meniscus knifeMeniscus knifeClass I
Bone holding forcepsBone holding forcepsClass I
Instrument tray reusableInstrument tray reusableClass I
Cartilage biomatrix implant animal-derivedCartilage biomatrix implant animal-derivedClass I
Arthroscopic shaver system blade single-useArthroscopic shaver system blade single-useClass I
Surgical power tool system control unit line-poweredSurgical power tool system control unit line-poweredClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptor
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass IIb
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass III
Endoscope camera adaptorEndoscope camera adaptorClass III
Endoscope camera adaptorEndoscope camera adaptorClass III
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass III
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass IIa
Endoscope camera adaptorEndoscope camera adaptorClass IIa
Endoscope camera adaptorEndoscope camera adaptorClass IIa
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Endoscope camera adaptorEndoscope camera adaptorClass I