12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15
FDA 510(k)
FDA Class 2
·Dental
PALOMAR SLP 1000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VANGUARD CR FEMORAL 70 MM RIGHT-INTERLOK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 2, 2017
BIOMET MODULAR FINNED STEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 2, 2017
VANGUARD CR TIBIAL BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 2, 2017
VANGUARD SERIES A STANDARD PATELLA
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 2, 2017
ILAB ULTRASOUND IMAGING SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (CE)·Product code IYO·May 2, 2013
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JIX·September 15, 2014
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011
BD SYRINGE 3ML HEPARIN
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NZW·September 9, 2019
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019