11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336
FDA 510(k)
FDA Class 2
·Radiology
AMARA
FDA UDI
Respironics, Inc.·00606959007185·AMARA HEADGEAR, RS, RP
BD SYRINGE 20ML LL BNS
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·October 28, 2025
QUICK COMBO PAD
FDA Adverse Event
Injury
·PHYSIO CONTROL CORP.·Product code MLN·January 17, 1997
UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
STARION CAUTERY HOOK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ISODUR PROSTHESIS HEAD 12/14 32MM XL
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014
UNIFY CRT-D, DF4 CONNECTOR
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 2, 2013
PULSE GEN MODEL 105
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·September 15, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 16, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012