9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
xTAG Gastrointestinal Pathogen Panel (GPP)
FDA 510(k)
FDA Class 2
·Microbiology
MultiPulse HoPLUS
FDA UDI
Asclepion Laser Technologies GmbH·04058784001009·Holmium Laser for Surgery
REJUVENATE MONOLITHIC SIZE 4 HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
PERFSCAPE V2.0
FDA 510(k)
FDA Class 2
·Radiology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 19, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 14, 2013
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·September 26, 2008
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 10, 2016
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018