13 results
·
28ms
·
Sources: EU EUDAMED, US FDA
FLEXIBLE IMMERSIBLE HYSTEROSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Vyaire
FDA UDI
Jaeger Medical GmbH·14250892903153·MicroGard II, Filter Kit
Jaeger
FDA UDI
Jaeger Medical GmbH·14250892907205·MicroGard IIC, Filter Kit
MEDTRONIC EXTENDED INFUSION SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 20, 2024
MEDTRONIC EXTENDED INFUSION SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 20, 2024
MOISTURE TRAP
FDA 510(k)
FDA Class 1
·Anesthesiology
EMG-UT 30
FDA 510(k)
FDA Class 2
·Neurology
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·June 24, 2014
EBICE MODEL 10D
FDA Adverse Event
Injury
·EBI, LLC·Product code ILO·November 8, 2010
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·December 18, 2012
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·September 25, 2023
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024