20 results
·
37ms
·
Sources: EU EUDAMED, US FDA
HUNTLEIGH FLOWPAC FP2000
FDA 510(k)
FDA Class 2
·Cardiovascular
Cook-Swartz Doppler Flow Probe
FDA 510(k)
FDA Class 2
·Radiology
TROJAN THINTENSITY BRAND MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·April 4, 2022
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·February 22, 2022
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·February 2, 2022
MONITOR 18 V DC POWER ADAPTER
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES IRELAND LIMITED·Product code GWM·April 15, 2014
S-ROM LINR MSER, 0 DEG, 28MM C
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code LPH·October 15, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 12, 2012
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·November 23, 2022
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·Product code ITX·May 25, 2021
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·April 16, 2024
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·April 2, 2024
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Malfunction
·COOK VASCULAR INC·Product code ITX·September 5, 2018
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Malfunction
·COOK VANDERGRIFT INC·Product code ITX·October 31, 2023
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·October 26, 2023
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Malfunction
·COOK VANDERGRIFT INC·Product code ITX·February 19, 2021
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·February 19, 2021
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Malfunction
·COOK VANDERGRIFT INC·Product code ITX·February 19, 2021
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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