12 results
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35ms
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Sources: EU EUDAMED, US FDA
PROGESTERONE CLASP RADIOIMMUNOASSAY KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994287861·CASE 9871211 INNER
NA
FDA UDI
KEY SURGICAL, INC.·10849771049408·K-Wires, Double diamond, .035-inch (0.9mm) diam...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293036·
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484542·K-Wire w. double end lanzet point _x000D_...
K-Wire w. double end lanzet point 0.9mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM712110·K-Wire w. double end lanzet point
0.9mm/...
OIC External Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
COBAS C 111 ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 13, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 12, 2012
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 15, 2010
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