18 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221117150·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221117000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221117070·
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
NA
FDA UDI
DEPUY MITEK, LLC·10886705007486·Flat Washer 17mm
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205004031·Luna Opal MB Mini .022 LL4 (-12°T +2°A)
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746154348·COSMETIC SL EMPOWER CLEAR INTERACT UR CEN 022 T...
Empower Clear Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746200236·COSMETIC SL EMPOWER CLEAR INTERACT UR CEN 022 T...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167310221117110·
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746000669·COSMETIC SL EMPOWER CLEAR INTERACT UR CENTRAL 0...
TTI THERMOMED MODEL 1.8 INSTRUMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NDX ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
Alteon
FDA UDI
Exactech, Inc.·10885862513564·ALT NECK TRL STD SZ11-17
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 24, 2011
URETEX TO2 URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·May 10, 2013
AUTOPULSE® LI-ION BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code DRM·November 3, 2014
3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire.
FDA Enforcement
Class II
·Ongoing·Arthrex, Inc.·November 21, 2018