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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ACL AcuStar

FDA 510(k)
FDA Class 2 ·Hematology

INTEGRAL X-SERIES HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304182486·

Avanta CMC

FDA UDI
Stryker GmbH·00886385025698·CMC, Metacarpal Impactor

INTEGRAL X-SERIES HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304182196·

Denovo Preformed Matrix Band

FDA UDI
Denovo Dental, Inc.·00810059290945·Denovo Preformed Matrix Band - Pediatric 3/16, ...

General Instruments

FDA UDI
ALPHATEC SPINE, INC.·00840180533550·SIGMA LTP SUCTION TUBE, #14 - 160MM

Responsive Orthopedics Total Knee Arthroplasty System

FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107330·TRIAL 90-SRK-170314 POLY UCCS 3X14MM

STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED)

FDA 510(k)
FDA Class 1 ·General Hospital

IMNS MEDACTA NAVIGATION SYSTEM,33.221000US

FDA 510(k)
FDA Class 2 ·Neurology

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

EASYTRAK 2

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code OJX·July 20, 2011