10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODULAR HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VERTEX® Reconstruction System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902293580·BONE SCREW 6900628 4.0MMX28MM CORT TI
Lower Crown Kit for Herbst
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199006280·
TCP
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420117960·
DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
UNKNOWN DEPUY SCREW
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.-1818910·Product code HWC·June 27, 2014
3 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 8, 2010
COULTER® LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code GKZ·January 8, 2013
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