11 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Surgical Trays
FDA 510(k)
FDA Class 2
·General Hospital
TRS-2000 POWER TILT/POWER RECLINE SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX
FDA 510(k)
FDA Class 2
·Cardiovascular
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·March 31, 2025
QUATERA 700 BIMANUAL I/A HANDPIECE SET
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code FSO·September 8, 2023
CLINICAL CHEMISTRY LACTATE DEHYDROGENASE
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code CFJ·December 14, 2017
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014
FREESTYLE FREEDOM LITE
FDA Adverse Event
Malfunction
·Product code NBW·August 15, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 9, 2013
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021