16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMPLANT, SILICONE AND TANTALUM
FDA 510(k)
FDA Class 2
·Ophthalmic
Ceramill TEMP
FDA UDI
Merz Dental GmbH·D709760550·Ceramill TEMP light 98x20 N/US
Spectrum, Inc.
FDA UDI
SPECTRUM, INC.·00850301007891·Strap-Stroll Stockinette, 6" X 5', Sterile
TIGER Spine System
FDA UDI
CORELINK LLC·M7257760550·5500 SERIES CANNULATED SCREW - MONO-AXIAL - 10...
TIGER Spine System
FDA UDI
CORELINK LLC·M72577605500·5500 SERIES CANNULATED SCREW MONO-AXIAL 10.5MM ...
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809763494253·MIS Cannulated Screw, Ø10.5 x 50mm, Ø6.0mm Rod
Symmetry Loute
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482125090·Symmetry® Tightener; Loute Wire; 8 1/2 in
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110638·COAXIAL IRR-ASP TIP STR W/SILICONE 0.3MM
KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386
FDA 510(k)
FDA Class 2
·Radiology
MONITOR, PATIENT (MODEL 78331A)
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 19, 2013
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES, ABBOTT VASCULAR CLONMEL·Product code MAF·July 15, 2010
REFOBACIN PLUS BONE CEMENT 40
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·September 3, 2024
POLISHED FINNED TIB TRAY 75MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 27, 2024
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025