11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROBLAB, MICROLOOP
FDA 510(k)
FDA Class 2
·Anesthesiology
ZOLL IVTM QUATTRO CATHETER
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code NCX·January 23, 2021
CONTOURS VSP III VOLAR PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIOPRO SUBTALAR IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 14, 2024
INFINIX
FDA Adverse Event
Other
·TOSHIBA AMERICA MEDICAL SYSTEMS, INC.·Product code JAA·April 3, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 4, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 28, 2011
GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 25, 2017
ZOLL IVTM QUATTRO CATHETER
FDA Adverse Event
Death
·ZOLL CIRCULATION·Product code NCX·July 14, 2020
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014