10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Symmetry Beckman-Adson
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482041246·Symmetry® Retractor, Beckman-Adson Laminectomy,...
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·November 19, 2002
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962160848·BECKMANN ADSON LAMINECTOMY RETRACTOR, 12 1/8", ...
Trigon HA Stand-Alone Wedge Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Tellos ISQ Buddy
FDA 510(k)
FDA Class 1
·Dental
EXCELSIOR SL-10 150CM 2 TIP
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR CORK·Product code DQY·November 11, 2014
CRE¿ WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KOG·September 12, 2011
MX-PRO R-3 AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 23, 2013
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