11 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIOWAVE LOW LEVEL COLD LASER SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
ENDOVASCULAR GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
VU CPOD INTERVERTEBRAL BODU FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 8, 2016
KIT RSV 30 TEST HOSPITAL VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 15, 2021
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
TOTAL ASR FEM IMP SIZE 39
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·June 1, 2011
FARGO "GP EXPRESS"
FDA Adverse Event
Other
·GP SPECIALISTS·Product code HPX·August 12, 2008
VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·December 29, 2021
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·September 29, 2023
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021