7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
ALERE I INFLUENZA A & B
FDA 510(k)
FDA Class 2
·Microbiology
MANTRA TENS MODEL NT3
FDA 510(k)
FDA Class 2
·Neurology
OLYMPUS
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FTJ·November 21, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·September 9, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·July 22, 2013
various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow Replacement
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 26, 2017