12 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOPHOTAS CELLUMA3
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SR PIP
FDA UDI
Stryker GmbH·00886385019826·SIZE 4: PIP DISTAL TRIAL
Symmetry Overholt-Geissendoerfer
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482056844·Symmetry® Forceps, Overholt Dissecting, Full
SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWDERED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·October 14, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 21, 2011
OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code KOD·September 17, 2008
REVITAN DISTAL PART STRAIGHT, UNCEMENTED, 18/200
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·October 31, 2018
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·September 29, 2023
EVEREST ® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·STRYKER-SPINE·Product code LXH·September 9, 2019
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012