12 results
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19ms
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Sources: EU EUDAMED, US FDA
STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
FDA 510(k)
FDA Class 2
·Neurology
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125525·PowerChem Neoprene Exam Gloves, Small
AURENORM 75 KF
FDA 510(k)
FDA Class 2
·Dental
DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
FDA 510(k)
FDA Class 1
·General Hospital
SYRINGE 3ML LL W/NDL 22X1 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 4, 2021
PINNACLE MTL INS NEUT44IDX64OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 15, 2011
ULTRAFLEX? ESOPHAGEAL NG
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code ESW·April 22, 2013
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·July 2, 2008
cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024