10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221718000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221718150·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221718070·
A-V FOOT PUMP
FDA 510(k)
FDA Class 2
·Cardiovascular
INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY
FDA 510(k)
FDA Class 2
·Dental
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 3, 2014
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·August 15, 2011
HEAVY DUTY TRAPEZE 200LB. PULL WEIGHT
FDA Adverse Event
Injury
·MIZUHO / HILL-ROM·Product code FMR·July 5, 2013
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020