8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST
FDA 510(k)
FDA Class 1
·Microbiology
Apple-Hunt Secondary Cannula
FDA UDI
Coopersurgical, Inc.·00888937004038·Apple-Hunt Secondary Cannula™ Pyramidal Tip; 7m...
ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY
FDA 510(k)
FDA Class 2
·Cardiovascular
KM-10 TENS ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·June 27, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 17, 2010
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·December 12, 2012
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020