11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bernafon
FDA UDI
Bernafon AG·05711584087541·ZR1, KIT 10 75 PB BE ZERENA 1
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776199975·Lletz ViewMore Med ET
OsteoMed
FDA UDI
OSTEOMED LLC·00845694015400·2.0mm x 34mm Cannulated Lag Screw
OsteoMed
FDA UDI
OSTEOMED LLC·00845694070409·Cannulated 2.0 x 34mm Lag Screw Sterile Qty 5
POWDER FREE NITRILE EXAMINATION GLOVES, BLACK
FDA 510(k)
FDA Class 1
·General Hospital
BLUE SKY BIO DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 20, 2013
UNKNOWN DEPUY FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·October 6, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
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