10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
IMMULITE HLH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WEDGE ELEV. BLUE VINYL OVERSIZE BOX
FDA UDI
ALIMED, INC.·00733657237191·
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113225·PS Insert, Size 4 x 11mm
NUVASIVE TRIAD FACET SCREW SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
K 520411-2, Hercep Test, 35Test, HER2, Protein
FDA Recall
Terminated
·Dakocytomation California Inc·Product code MVC·September 29, 2005
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 17, 2013
COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 10, 2010
ZEPHYR XL SR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012