9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Advisor VL Circular Mapping Catheter, Sensor Enabled
FDA 510(k)
FDA Class 2
·Cardiovascular
Bernafon
FDA UDI
Bernafon AG·05711584087572·ZR1, KIT 10 85 PB BE ZERENA 1
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776199999·LLETZ INSULATED VIEWMAI SPECULUM GRAVES LARGE
AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) ACCESS PORT I
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·October 6, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 4, 2011
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 20, 2013
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