7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CHILDREN'S SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MATRIX ELECDT & VACUPULLS
FDA 510(k)
FDA Class 2
·Neurology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 14, 2013
EYE SURGERY STRETCHER
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code FPO·December 4, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 3, 2014
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·August 26, 2015