32 results · 26ms · Sources: EU EUDAMED, US FDA

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SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices

FDA 510(k)
FDA Class 2 ·Orthopedic

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690189428·Apex Revision Knee System - Revision Tibia Ream...

Ophthalmic Retractor

FDA UDI
KATENA PRODUCTS, INC.·00841668101100·HELVESTON "GREAT BIG BARBIE" RETRACTOR 11MM

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690189411·Apex Revision Knee System - Revision Tibia Ream...

OTOMAG BONE CONDUCTION HEARING SYSTEM

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

CONDUCTOR CORONARY GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

REZUM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·March 13, 2026

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LIT·September 12, 2019

REZUM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·January 13, 2026

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 21, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

HEARTSTART FRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 18, 2013

XEN 45 GTS

FDA Adverse Event
Injury ·ALLERGAN (IRVINE)·Product code KYF·February 11, 2022

XEN 45 GTS

FDA Adverse Event
Injury ·ALLERGAN (IRVINE)·Product code KYF·February 11, 2022

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025