76 results · 39ms · Sources: EU EUDAMED, US FDA

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Acuson SC2000 Diagnostic Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

INTEGRAL X-SERIES HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304182493·

INTEGRAL X-SERIES HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304182202·

Denovo Preformed Matrix Band

FDA UDI
Denovo Dental, Inc.·00810059290952·Denovo Preformed Matrix Band - Pediatric 3/16, ...

Ambler Surgical

FDA UDI
AMBLER SURGICAL CORP.·00190660131494·Barr self-retaining anal retractor, 8'', 2 3/4'...

12 LEAD GLOVE

FDA 510(k)
FDA Class 2 ·Cardiovascular

LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ALERE DETERMINE HIV 1/2 AG/AB COMBO

FDA Adverse Event
Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·June 12, 2018

ALINITY I TOTAL B-HCG REAGENT KIT

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

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 1, 2020

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

8/10 DILATOR/SHEATH SET

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code EZN·October 14, 2014