15 results
·
29ms
·
Sources: EU EUDAMED, US FDA
ANTERIOR CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984342·anteriors; shade B3; mould R 87
SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NOVAPATH SPECIMEN COLLECTION KIT
FDA 510(k)
FDA Class 1
·Microbiology
ALINITY I TSH REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·March 20, 2026
ALINITY I TSH REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·April 16, 2026
ARCHITECT TSH
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·April 15, 2026
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013
LIGACLIP MCA SMALL APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDO·August 6, 2014
SYNCHRON® LX20 PRO ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·February 10, 2011
ALINITY I TSH REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·November 5, 2025
ALINITY I TSH REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·September 15, 2025
ARCHITECT TSH
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·September 5, 2025
ARCHITECT TSH REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·November 19, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024