8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Expandable Lumbar Fusion Cage (Type I,Type II)
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
SYNTHES (U.S.A.) LP·10886982159847·3.5MM 90 DEG CANN LC-ANGLED BLADE PLATE 6 HOLES...
WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DESARA MESH, DESARA BLUE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FMF·November 7, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·September 1, 2011
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 17, 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