15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GOLFF Sterile Anti-Fog Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MILAGRO
FDA UDI
Medos International Sàrl·10886705022274·MILAGRO ADVANCE INTERFERENCE SCREW Absorbable -...
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022526·400 micron core/730 micron OD Luer Lock Diode L...
Ophthalmic Spoon
FDA UDI
KATENA PRODUCTS, INC.·00841668102206·LASEK ALCOHOL WELL 9.5MM
LifePath Remote Patient Monitoring Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRAEXTEND USWS-900A V2.1 AND V3.1
FDA 510(k)
FDA Class 2
·Radiology
MENTOR SMOOTH ROUND SPECTRUM
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·March 25, 2019
MENTOR SMOOTH ROUND SPECTRUM
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·March 25, 2019
FREEDOM ONBOARD BATTERY
FDA Adverse Event
Malfunction
·SYNCARDIA SYSTEMS, INC.·Product code LOZ·October 15, 2014
ENDOSTAT ELECTROSURGICAL UNIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·September 1, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·July 15, 2013
MILAGRO ADVANCE SCREW 9X30MM
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HWC·January 23, 2019
MILAGRO ADVANCE SCREW 9X30MM
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code HWC·February 27, 2019
MILAGRO ADVANCE SCREW 9X30MM
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HWC·September 12, 2018
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022