9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Delta III Pro
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
FDA 510(k)
FDA Class 2
·Radiology
Electric breast pump (Models: RH-228 and RH-338)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CAPTURE-R READY SCREEN
FDA Adverse Event
Malfunction
·IMMUCOR·Product code KSZ·August 30, 2006
TRIDENT HEMISPHERICAL MULTI
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·November 4, 2008
EPIC II CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 21, 2011
6000CMS IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·July 5, 2013
OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903
FDA 510(k)
FDA Class 2
·Orthopedic
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024