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