16 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PHILIPS INTEGRIS I 2000 SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ReLine
FDA UDI
Nuvasive, Inc.·00195377068750·RELINE C Screw, 4.0x12mm MA
TRU UCLA Abutment NP Non-Engaging - Plastic
FDA UDI
STERNGOLD DENTAL LLC·00841549110207·TRU UCLA Abutment NP Non-Engaging - Plastic. T...
SPEEDPASS DISPOSABLE
FDA UDI
Biomet Orthopedics, LLC·00880304464230·
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482129708·Symmetry® Monopolar Electrode; L Hook w/Valve; ...
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837014384·
SWAN-GANZ THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·May 11, 2009
CAPNOSTREAM20 WITH MICROMEDICO2 MODULE
FDA 510(k)
FDA Class 2
·Anesthesiology
IMPRA CARBOFLO EPTFE VASCULAR GRAFTS
FDA 510(k)
FDA Class 2
·Cardiovascular
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962151983·SPATULA SUCTION COAGULATOR, 12 1/2", W/VALVE
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 9, 2015
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 9, 2013
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014
SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Right, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904012. Used to pass suture through tissue.
FDA Recall
Terminated
·Biomet, Inc.·Product code MDM·June 18, 2010
Shoulder Pack, part number AMS2936 Shoulder Pack, part number AMS3638 Shoulder Pack, part number AMS3711(B Shoulder Pack, part numbere AMS4212 Shoulder Pack, part number AMS6460 Shoulder Pack, part numberPSS1852(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
FDA Enforcement
Class I
·Ongoing·Zyno Medical LLC·June 18, 2025