11 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Alpha Endo Handpiece (Alpha Endo)
FDA 510(k)
FDA Class 1
·Dental
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011252223200·ceraMotion® Me Chroma Concept Opaque 3, 20 g / ...
ACCESS EPO ASSAY
FDA 510(k)
FDA Class 2
·Hematology
Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
FDA 510(k)
FDA Class 2
·Anesthesiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 26, 2013
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·January 27, 2026
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Death
·ZOLL LIFECOR CORPORATION·Product code MVK·December 3, 2008
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·September 16, 2011
GYNECARE MORCELLEX TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code HET·July 29, 2013
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·May 18, 2018
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024