20 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
36M - Enbridge - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588080741·36M - Enbridge - Metal
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ULTRA-LITE 5 TURBO LIGHT CURE UNIT
FDA 510(k)
FDA Class 2
·Dental
ACUTRAK SCREW
FDA Adverse Event
Malfunction
·ACUMED LLC·Product code HWC·January 23, 2019
ACUTRAK SCREW
FDA Adverse Event
Malfunction
·ACUMED LLC·Product code HWC·January 23, 2019
ACUTRAK SCREW
FDA Adverse Event
Malfunction
·ACUMED LLC·Product code HWC·January 23, 2019
ACUTRAK SCREW
FDA Adverse Event
Malfunction
·ACUMED LLC·Product code HWC·January 23, 2019
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·June 15, 2023
ACUTRAK SCREW
FDA Adverse Event
Injury
·ACUMED LLC·Product code HWC·January 23, 2019
ACUTRAK SCREW
FDA Adverse Event
Injury
·ACUMED LLC·Product code HWC·January 23, 2019
ACUTRAK SCREW
FDA Adverse Event
Injury
·ACUMED LLC·Product code HWC·January 23, 2019
ACUTRAK SCREW
FDA Adverse Event
Injury
·ACUMED LLC·Product code HWC·January 23, 2019
ACUTRAK SCREW
FDA Adverse Event
Injury
·ACUMED LLC·Product code HWC·January 23, 2019
ACUTRAK SCREW
FDA Adverse Event
Injury
·ACUMED LLC·Product code HWC·January 23, 2019
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Death
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 11, 2011
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·July 2, 2013
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021