45 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MISSION U500 URINE ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780736·LEVAMED ACTIVE ANKLE SUP SLVR L I
n/a
FDA UDI
Ortho Development Corporation·00822409076079·Femoral Broach/Trial 1221
Vesper Custom Tape
FDA UDI
Lemaitre Vascular, Inc.·00840663110339·Vesper Custom Tape
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962162859·IRIS OPERATING SCISSORS - CVD 9cm/3.5'
JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100
FDA 510(k)
FDA Class 2
·Cardiovascular
PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STEALTHSTATION S8 PREMIUM SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·March 27, 2020
CATHETER MOUNT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZO·June 6, 2012
MAXI 500
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH MAGOG INC.·Product code FSA·April 19, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014
ATS 1200 TOURNIQUET SYSTEM
FDA Adverse Event
Injury
·ZIMMER SURGICAL·Product code KCY·May 11, 2011
BD DISCARDIT¿ II SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 17, 2023
BD PHASEAL OPTIMA INJECTOR (N35-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·August 2, 2019
BD PHASEAL¿ OPTIMA SYSTEM, INJECTOR, N35-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·August 5, 2019
INFANT BIAS FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 12, 2012
ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·July 31, 2012
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·October 11, 2012
CONNECTOR C35-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·April 30, 2021
BD PHASEAL¿ OPTIMA CONNECTOR (C35-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·October 14, 2021