9 results
·
37ms
·
Sources: EU EUDAMED, US FDA
GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIAMONDS BURS-COMPOSIT FINISHING
FDA 510(k)
FDA Class 1
·Dental
ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
E-POLY 40MM +3 HIWALL LNR SZ24
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code OIY·February 3, 2020
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·June 16, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 19, 2010
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·December 15, 2012
CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024