8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
SURGITEK SIZER FOR PENILE PROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LEAVE ACTIVE PFC CVD 10MM SZ5
FDA Adverse Event
Injury
·K830927·Product code JWH·April 18, 2012
HEALIX ADVANCE KNOTLESS BR ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130
FDA 510(k)
FDA Class 2
·Anesthesiology
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 23, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 13, 2012
BRIGTHVIEW XCT
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS, INC·Product code KPS·September 7, 2010
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018