11 results
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19ms
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Sources: EU EUDAMED, US FDA
NXSTAGE DIALYSATE PREPARATION MODULE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Mini Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70602961·Mini-Mono-Brackets 4th Dim. Ricketts 'S' .018" ...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306813481·Russian Tissue Forceps, 30cm
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
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 11, 2013
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·August 25, 2014
PROFEMUR(R) Z STEM PLASMA SPRAYED
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·April 15, 2011
UNKNOWN
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·June 8, 2018
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024