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

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Cardinal HealthTM Poly-Coated Open-Back Protective Gown

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

Ophthalmic Retractor

FDA UDI
KATENA PRODUCTS, INC.·00841668100981·DESMARRES LID RETRACTOR #3

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A182830150·18mm H x 28mm W x 30mm L x 15 degrees ALIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A18283080·18mm H x 28mm W x 30mm L x 8 degrees ALIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A182830120·18mm H x 28mm W x 30mm L x 12 degrees ALIF

MUSTMINI OCCIPITAL SCREW

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025

ELECTROCARDIOGRAPH

FDA 510(k)
FDA Class 2 ·Cardiovascular

INFX-8000H, INFINIX-I

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 14, 2025

TERUMO CDI 500 BLOOD PARAMETER MONITOR

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DRY·July 8, 2011

R SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 11, 2013

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·October 17, 2014

Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.

FDA Enforcement
Class II ·Terminated·Intersurgical Inc·January 15, 2020

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025

MUSTMINI OCCIPITAL SCREW

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025

MUST MINI OC PRE-BENT TRANSITION ROD 75° Ø3.5/4X 200MM (STE)

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKG·April 25, 2024