12 results
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17ms
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Sources: EU EUDAMED, US FDA
REBREATHER BAGS
FDA 510(k)
FDA Class 1
·Anesthesiology
Everest & Jennings
FDA UDI
GF HEALTH PRODUCTS, INC.·M36889402201·DURA-GEL SPP-AT
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780415084·Integra® Miltex® Tissue Nipper, 4", Straight Jaws
SpiritMB
FDA UDI
ORMCO CORPORATION·00889989007015·ID G - Twin - Upper-Right Lateral - Red
Bioseal Inc.
FDA UDI
BIOSEAL·00630094194028·Baby Blankets Kidsplay
NTI
FDA UDI
NTI - Kahla GmbH Rotary Dental Instruments·E3108061043585142201·NTI SuperFlex DS Diamond Disc
Aulisa Temperature Module (TM0002)
FDA 510(k)
FDA Class 2
·General Hospital
MEDICAL AIR COMPRESSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
ZELTIQ COOLCORE (6.3)
FDA Adverse Event
Injury
·ZELTIQ AESTHETICS INC.·Product code OOK·June 19, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·December 9, 2010
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020