10 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HairCheck-DT (Cocaine)
FDA UDI
Quest Diagnostics·00868586000216·HairCheck-DT (Cocaine) is an ELISA test kit use...
Geneva
FDA UDI
Nucletron B.V.·08717213056190·Interstitial Ovoid 30mm 2
TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STARDRIVE SCREWDRIVER SHAFT T8 105MM
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code KWQ·September 27, 2016
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013
PLUM 1.6 W/DATAPORT
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 23, 2011
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014