12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TxRx Knee 15 Flare MR Coil 3.0T
FDA 510(k)
FDA Class 2
·Radiology
Pinehurst Anterior Cervical Plate System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215030827·
Aquila Anterior Cervical Plate System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215125882·
AXIS-V MONOCHROME 5 MP DISPLAY
FDA 510(k)
FDA Class 2
·Radiology
CORVIS ST
FDA 510(k)
FDA Class 2
·Ophthalmic
ALPHA I INFLATABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·MENTOR UROLOGY, INC.·Product code FHW·April 8, 1997
TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/17 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 20, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 25, 2025
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 11, 2013
ATN LAG SCREW 100MM STERILE
FDA Adverse Event
Injury
·DEPUY ACE S.A. 'R.L.·Product code HSB·July 8, 2011
MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM
FDA Adverse Event
Injury
·MICROSULIS MEDICAL LTD.·Product code MNB·September 15, 2008
RECLAIM DISTAL TAPERED 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