35 results · 23ms · Sources: EU EUDAMED, US FDA

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NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Polystar Selection EDITION

FDA UDI
Merz Dental GmbH·D7091981424·anteriors; shade D4; mould IM6

Monster Screw System

FDA UDI
Paragon 28, Inc.·00889795049063·1.4mm x 240mm Cleaning Stylet

AFFIRM CO2 AND AFFIRM CO2 HP

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PeDIA

FDA 510(k)
FDA Class 1 ·Anesthesiology

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·November 20, 2025

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 18, 2026

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 3, 2026

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 5, 2026

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 16, 2026

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 28, 2026

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 30, 2026

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 17, 2026

RESTORE SENSOR

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 27, 2013

TUBING SUCTION 9/32"

FDA Adverse Event
Malfunction ·CAREFUSION CORP·Product code BYX·February 1, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·October 23, 2025

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·October 30, 2025

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·July 30, 2025

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·September 12, 2025