23 results · 24ms · Sources: EU EUDAMED, 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