16 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
FDA 510(k)
FDA Class 2
·Immunology
Nexxis OR
FDA UDI
Barco NV·05415334042346·NEXXIS WORKSPOT KIT2 CM
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471149816·K-WIRE - DOUBLE TROCAR FULLY THREADED 1.2mm DIA...
Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape
FDA 510(k)
FDA Class 2
·General Hospital
PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60
FDA 510(k)
FDA Class 2
·Ophthalmic
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024209893·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024209916·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024209879·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024209886·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024209909·
INS SAF SYR 1CC 29X1/2IN
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FMF·January 15, 2013
UNIVERSAL STEM 75X18MM FLUTED
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS 121965·Product code JWH·July 28, 2014
EON MINI 16-CHANNEL IPG
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·January 11, 2011
BC DISTRACTOR BODY END ACT. W/U-JOINT 30MM FOR CMF DSTR
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MQN·January 29, 2013
DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
FDA Enforcement
Class I
·Terminated·Synthes, Inc.·August 27, 2014
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