19 results
·
21ms
·
Sources: EU EUDAMED, US FDA
VISION VXC CENTRAL STATION, MODEL 4300
FDA 510(k)
FDA Class 2
·Cardiovascular
SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THE AUTOTAC SYSTEM
FDA 510(k)
FDA Class 2
·Dental
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 29, 2013
OASIS
FDA Adverse Event
Malfunction
·ATRIUM MEDICAL CORP.·Product code KDQ·June 3, 2008
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 18, 2011
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·February 16, 2017
LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·July 10, 2017
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·September 30, 2015
LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·December 4, 2017
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DQX·February 9, 2017
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DQX·December 19, 2018
LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·April 20, 2017
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DQX·June 16, 2017
LUNDERQUIST SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·May 31, 2017
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018