23 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FUJINON STERILE OVERTUBES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ORTHONE
FDA 510(k)
FDA Class 2
·Radiology
DORNIER LITHOTRIPTER 140(DOLI 140)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 18, 2025
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
VASOVIEW 6 ACCESSORY PACK
FDA Adverse Event
Malfunction
·MAQUET CV·Product code GCJ·January 10, 2019
UNIFY CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014
PANORAMA CENTRA MONITOR W/ TELEPACKS
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 17, 2011
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022
METASUL LDH, HEAD, 56, CODE V, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·April 27, 2018
METASUL LDH, HEAD, 56, CODE V, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWY·January 31, 2018
METASUL LDH, HEAD, 40, CODE F, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 13, 2018
METASUL LDH, HEAD, 44, CODE J, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KXA·October 24, 2017
METASUL HEAD 28MM L 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·August 7, 2018
METASUL HEAD 28MM L 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·August 3, 2018
METASUL, HEAD, M, 32/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·March 12, 2018
METASUL LDH, HEAD, 44, CODE J, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·February 22, 2018
ECHO BI-MTRC MICR RP SO 5X73
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 6, 2018