15 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Corin BiPolar-i
FDA UDI
CORIN LTD·05056139234552·Corin BiPolar-i Ø41/22mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694052276·.9mm Extended Twist Drill, 4mm STOP, Hex Shank
LGN PS HIGH FLEX XLPE SZ 1-2 13MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017
THE NIMBLE ROCKET POWERED WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
INFINITY MCABLE - MAINSTREAM CO2
FDA 510(k)
FDA Class 2
·Anesthesiology
LGN PS HIGH FLEX XLPE SZ 1-2 13MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·September 12, 2025
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·ABBOTT VASCULAR CLONMEL·Product code NIQ·July 19, 2010
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 8, 2013
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014
1.9FX50CM SINGLE LUMEN VASCU-PICC
FDA Adverse Event
Malfunction
·MEDCOMP·Product code LJS·April 15, 2011
MULTI-LINK MINI VISION RXCORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·September 16, 2010
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018