15 results · 29ms · Sources: EU EUDAMED, US FDA

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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