15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARK Fentanyl Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868240027·
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304555181·
POOLE SUCTION TUBE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896091542·POOLE SUCTION TUBE DELUXE WITH CUTOFF VALVE 30FR
OLYMPUS EMPOWER H65
FDA Adverse Event
Malfunction
·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022
FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY
FDA 510(k)
FDA Class 2
·Cardiovascular
WATCH-PAT MODEL 100S-2
FDA 510(k)
FDA Class 2
·Anesthesiology
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·August 1, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 3, 2011
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 17, 2014
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE·Product code ITI·July 27, 2011
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 10, 2021
KIT BD MAX ENTERIC VIRAL PANEL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code PCH·October 3, 2022
ROSA Brain 3.0 Application-Brain
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·February 19, 2020