14 results
·
25ms
·
Sources: EU EUDAMED, US FDA
SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE
FDA 510(k)
FDA Class 1
·Radiology
22MM DUOFLOW B/SYSTEM WITH LUER CONNECTOR INTEGRAL MONITORING LINE AND ELBOW 3M
FDA UDI
Intersurgical Incorporated·05030267163991·22MM DUOFLOW BREATHING SYSTEM WITH LUER CONNECT...
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113140·PS Insert, Size 3 x 10mm
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110980·STERILIZING CASE PLASTIC LARGE
Arthrex®
FDA UDI
ARTHREX, INC.·00888867058651·ECLIPSE & UNIVERS HNDL FOR DRLING TMPLT
DELTA PLAN II RADIATION THERAPY PLAN
FDA 510(k)
FDA Class 2
·Radiology
DAVLITE MICROENDOSCOPE & ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OT SURESTEP ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 17, 2013
MULTI-LINK CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA·Product code MAF·December 10, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 8, 2014
MARLEX MESH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·August 15, 2008
MARLEX MESH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·August 15, 2008
MARLEX MESH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·August 15, 2008
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015