16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CRYSTAL ULTRA
FDA 510(k)
FDA Class 2
·Dental
LINK Instruments - Impactors, extractors and insertion
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575033225·Orthopaedic prosthesis instrument, reusable - G...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450116913·
BINAX NOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 7, 2021
BINAX NOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 7, 2021
ZOLL PROPAQ MD
FDA 510(k)
FDA Class 2
·Cardiovascular
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 24, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 30, 2014
EON MINI IPG
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 14, 2011
TPRLC 133 MP T1 PPS SO 5X95MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·April 3, 2025
TPRLC 133 MP TYPE1 PPS HO 16.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·April 3, 2025
TPRLC 133 MP TYPE1 PPS SO 16.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·April 3, 2025
TPRLC XR MP T1 PPS 17X119MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·April 3, 2025
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013