15 results · 24ms · Sources: EU EUDAMED, 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