9 results
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27ms
·
Sources: EU EUDAMED, US FDA
HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
P.F.C.
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295215974·P.F.C. MODULAR PLUS FULL WEDGE TRIAL SZ 5 10 DEG
SPROTTE SPECIAL NRFit
FDA 510(k)
FDA Class 2
·Anesthesiology
NXSTAGE DIALYSATE PREPARATION MODULE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
10MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/300MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code JDS·September 19, 2017
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014
S5 ROLLER PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·November 27, 2012
WA1000B CRYOSURGICAL CONSOLE SYSTEM & CRYOTIP
FDA Adverse Event
Malfunction
·WALLACH SURGICAL DEVICES·Product code GEH·September 23, 2010
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012