9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ReNew V Handpiece Laparoscopic Instruments
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VENUS BASIC SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GENESIS PULSE GENERATOR, 8-CHANNEL
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 7, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 10, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2008
PIVET GUIDE EMBRYO TRANSFER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MQF·March 27, 2018
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
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