14 results
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25ms
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Sources: EU EUDAMED, US FDA
PERFOURM PUTTY SOFT
FDA 510(k)
FDA Class 2
·Dental
Convertors®
FDA UDI
Microtek Medical LLC·00748426263424·Convertors® Instrument Pouch
Spark™ TruColor™
FDA UDI
METREX RESEARCH, LLC·00810210820066·Spark™ TruColor™ headlight system - Internation...
Spark™ TruColor™
FDA UDI
METREX RESEARCH, LLC·00810210820059·Spark™ TruColor™ headlight system - Internation...
Spark™ TruColor™
FDA UDI
METREX RESEARCH, LLC·00810210820035·Spark™ TruColor™ headlight system - Internation...
Spark™ TruColor™
FDA UDI
METREX RESEARCH, LLC·00810210820042·Spark™ TruColor™ headlight system - Internation...
Spark™ TruColor™
FDA UDI
METREX RESEARCH, LLC·00810210820028·Spark™ TruColor™ headlight system - North Ameri...
REPROCESSED ELECTROSURGICAL INSTRUMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VORTEX ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·December 19, 2012
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·November 30, 2010
HOMECHOICE PRO
FDA Adverse Event
Death
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 2, 2014
CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024