14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PULPDENT SNOOP
FDA 510(k)
FDA Class 2
·Dental
MENS FREEDOM MICRO
FDA 510(k)
FDA Class 2
·Neurology
MA-2 AND MA2+2 VOLUME VENTILATORS
FDA 510(k)EXT SET, PUR SMALLBORE BIFUSE W/2 CLAVE¿
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·October 3, 2025
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
UNSPECIFIED CENTRAL LINE CONNECTOR
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·July 8, 2025
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 22, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·February 15, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 19, 2011
94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012