13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550148·GENUMEDI PT KNEE SUP SILVER L EW V
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122285·KWire .062x9" (1.6x225mm)
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776131821·YANKAUER SUCTION TUBE, 15"
REACH(R) FEMORAL PROVISIONAL
FDA UDI
Biomet Orthopedics, LLC·00880304307032·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111085093·SE METZ STAND SCISS CVD 8" TC
KIRSCHNER WIRES, STEINMAN PINS
FDA 510(k)
FDA Class 2
·Orthopedic
CONFIDANT 2.0
FDA 510(k)
FDA Class 2
·Cardiovascular
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 26, 2025
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 11, 2013
ASR ACETABULAR IMPLANT 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·July 7, 2011
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOSPHERE
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSD·September 3, 2008
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024