13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AccuLIF TL and PL Cage
FDA 510(k)
FDA Class 2
·Orthopedic
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193024589·B-P MODULAR EXTENSION W/ULTRACOAT - 15 MM X 175 MM
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613154020591·Cruciate Retaining Tibial Insert
VIDAS® EBV VCA IGM
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LGD·February 24, 2016
AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODIFICATION TO: CARDIMA ABLATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IOLMASTER 700
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·May 5, 2017
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 10, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 13, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2008
KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCICENCS IMPLANTS SA·Product code GWM·August 1, 2016
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