11 results
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26ms
·
Sources: EU EUDAMED, US FDA
SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE
FDA 510(k)
FDA Class 2
·Ophthalmic
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756390491·TOTAL JOINT PACK
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112342·SURG-I-BAND ORANGE GLOW
UCR
FDA UDI
Seaspine Orthopedics Corporation·10889981080273·5.0 mm Trial Rod Silicone Covered
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450226094·
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
CENTRIMAG RETURN CANNULA KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
INTERSTIM
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·November 23, 2010
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·January 11, 2013
FORTIFY ASSURA DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024