13 results
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18ms
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Sources: EU EUDAMED, US FDA
REMOVE ADHESIVE REMOVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OIC Intramedullary Screw System
FDA UDI
ORTHOPAEDIC IMPLANT COMPANY, THE·10811998031825·1.15mm x 150mm K-WIRE
Sklar®
FDA UDI
SKLAR CORPORATION·10649111246777·SB CUSCO SPEC SMALL W/TUBE
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955936579·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955938917·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955937743·Percutaneous Transluminal Angioplasty Balloon C...
ROMFLEX REHAB EQUIP EXTREMITIES UNIT
FDA 510(k)
FDA Class 1
·Physical Medicine
SOREX SAFE-AIR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·December 6, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 7, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·December 7, 2012
TAPERLOC POR FMRL 9X137
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·April 22, 2016
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