9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
3-WAY STOPCOCK WITH LUER-LOCK FITTING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197447928·Spurling SWIVEL Rongeur
15.0 c...
TEST, (IVDP) THYROID ANTIBODY
FDA 510(k)
FDA Class 2
·Immunology
Creavo Vitalscan Magnetocardiograph
FDA 510(k)
FDA Class 2
·Cardiovascular
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·April 24, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 3, 2012
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·July 19, 2010
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·October 3, 2012
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021