10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
WISCONSIN HEART RATE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
AP 34 MULTI-THERAPY INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
AVITA TSO/TS1 INFRARED EAR THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 23, 2012
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS SLC·Product code JAA·December 30, 2013
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 17, 2010
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024