48 results
·
22ms
·
Sources: EU EUDAMED, US FDA
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
FDA 510(k)
FDA Class 2
·Cardiovascular
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317300225·
Champion 4-piece valve kit
FDA UDI
GA Health Company Limited·04897106957989·
andorate® 4-piece valve kit
FDA UDI
GA Health Company Limited·04897106958627·
andorate® Champion 4-piece valve kit
FDA UDI
GA Health Company Limited·04897106955565·
Tasso+ Convenience Kit
FDA UDI
Tasso Inc.·00850038691028·
CANDELA SPTL-1E PULSED DYE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GENERIC BLOOD GLUCOSE TEST STRIP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UNKNOWN_INSTRUMENTSTIRE_PRODUCT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP·Product code HBE·June 24, 2021
UNKNOWN_INSTRUMENTS_PRODUCT
FDA Adverse Event
Injury
·Product code HWE·July 7, 2021
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 9, 2013
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 24, 2011
PROTEGE RX CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·COVIDIEN·Product code NIM·July 26, 2021
ANSPACH EMAX 2 PLUS HAND PIECE - ROHS
FDA Adverse Event
Injury
·BLUE BELT TECHNOLOGIES·Product code OLO·November 20, 2020
CHROMID® CARBA SMART
FDA Adverse Event
Malfunction
·BIOMERIEUX S.A.·Product code JSO·August 23, 2018
NAVIO
FDA Adverse Event
Malfunction
·BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW·Product code OLO·November 21, 2017
NAVIO
FDA Adverse Event
Injury
·BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW·Product code OLO·December 26, 2017
NAVIO
FDA Adverse Event
Injury
·BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW·Product code OLO·November 2, 2017
NAVIO SOFT TISSUE PROTECTOR
FDA Adverse Event
Injury
·BLUE BELT TECHNOLOGIES·Product code OLO·July 24, 2020