78 results · 22ms · Sources: EU EUDAMED, US FDA

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SunCHECK

FDA 510(k)
FDA Class 2 ·Radiology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699595·GENUMEDI PSS BLUE, SIZE VII

INTEGRAL X-SERIES HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304182417·

Denovo Preformed Matrix Band

FDA UDI
Denovo Dental, Inc.·00810059290877·Denovo Preformed Matrix Band - Pediatric 3/16, ...

STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT

FDA 510(k)
FDA Class 2 ·Dental

GELSCAN, MODEL 1206

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ALINITY I TOTAL B-HCG REAGENT KIT

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

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 1, 2026

ALINITY I TOTAL B-HCG REAGENT KIT

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

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 6, 2026

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·August 18, 2025

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 20, 2026

ALINITY I TOTAL B-HCG REAGENT KIT

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

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 22, 2026

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 22, 2026

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 6, 2026

COAGUCHEK ® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·June 14, 2013

INSIGNIA

FDA Adverse Event
Malfunction ·GUIDANT CLONMEL IRELAND·Product code NVZ·July 20, 2011

MULLINS TRANSSEPTAL CATHETER INTRODUCER SET - 8F

FDA Adverse Event
Malfunction ·MEDTRONIC INC.·Product code DTB·September 12, 2008

ALINITY I TOTAL B-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 29, 2026