12 results
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21ms
·
Sources: EU EUDAMED, US FDA
VAN-TEC DEFLECTING ROTATING SEGURA BASKET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL
FDA 510(k)
FDA Class 2
·Dental
FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)
FDA 510(k)
FDA Class 2
·Anesthesiology
SULOX, HEAD, M, 32/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·May 31, 2018
AVENIR MUELLER, STEM, STANDARD, UNCEMENTED, HA, 4, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·May 31, 2018
DURASUL, ALPHA INSERT, HH/32
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·May 31, 2018
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Malfunction
·MPRI·Product code NVN·June 10, 2014
ACCU-CHEK ® PERFORMA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 7, 2010
PONTO WIDE IMPLANT WITH ABUTMENT
FDA Adverse Event
Other
·OTICON MEDICAL AB·Product code MAH·November 23, 2012
ALLOFIT ALLOCLASSIC SHL 50/HH
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·May 31, 2018
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023