8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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uMI Panorama
FDA 510(k)
FDA Class 2
·Radiology
BD BBL™ Sensi-Disc™ Isoniazid - 5 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902315728·Disc Isoniazid Inh-5 1 Ea
MICRO AMBULATORY ECG RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923
FDA 510(k)
FDA Class 2
·Orthopedic
OLYMPUS REUSABLE SURGICAL SCISSORS
FDA Adverse Event
Other
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·August 23, 2011
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 17, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022