9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Selux AST System; Model AST Gen 1.0
FDA 510(k)
FDA Class 2
·Microbiology
Luer-Lock-Tips
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2117591·Luer-Lock-Tips. Suitable for: LuxaFlow, LuxaFlo...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2024
RADIUS NEXT GENERATION GUIDEWIRE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
.DECIMAL ELECTRON APERTURE
FDA 510(k)
FDA Class 2
·Radiology
HEMOCHRON
FDA Adverse Event
Malfunction
·INTERNATIONAL TECHNIDYNE CORPORATION (ITC)·Product code GKP·October 14, 2008
ASR ACETABULAR CUPS 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 8, 2013
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014