14 results · 34ms · Sources: EU EUDAMED, US FDA

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DSL INSULIN RIA (DSL 1600)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MICROZYME T3 ENZYME IMMUNOASSAY KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VPW 2877E6 X-RAY POWER SUPPLY

FDA 510(k)
FDA Class 1 ·Radiology

LIBERTY CYCLER

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·July 13, 2015

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 15, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 4, 2014

EMBOGUARD

FDA Adverse Event
Malfunction ·NEURAVI LTD.·Product code QJP·February 18, 2026

QUICKSET ACE GRATER HEAD 52MM

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code HTO·August 19, 2019

QUICKSET ACE GRATER HEAD 46MM

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code HTO·August 19, 2019

QUICKSET ACE GRATER HEAD 55MM

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code HTO·August 19, 2019

QUICKSET ACE GRATER HEAD 47MM

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code HTO·August 19, 2019

QUICKSET ACE GRATER HEAD 48MM

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code HTO·August 19, 2019

QUICKSET ACE GRATER HEAD 53MM

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code HTO·August 19, 2019

PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017