10 results
·
34ms
·
Sources: EU EUDAMED, US FDA
SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE
FDA 510(k)
FDA Class 1
·Dental
FT4, FREE THYROXINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016
DERMADAPT WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IN TOUCH ZU
FDA Adverse Event
Malfunction
·FLEXTRONICS EMS CANADA·Product code FNL·January 17, 2013
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·January 10, 2011
UNKNOWN DEPUY LCS STD+/LRG 10MM MENISCAL BEARINGS
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.1818910·Product code JWH·July 28, 2014
ELECSYS TSH ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020
FT3 - FREE TRIIODOTHYRONINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CDP·October 10, 2014
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024