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

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Single Use Injector

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)

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

LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR)

FDA 510(k)
FDA Class 1 ·General Hospital

MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE

FDA Adverse Event
Injury ·ACCESSCLOSURE, INC.·Product code MGB·October 22, 2014

INTERMATE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·August 5, 2011

HEART START XL

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 19, 2013

RHYTHMIA HDX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025

COOK COPE-LOOP CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code LJE·August 23, 2021

ULTRATHANE SUPRAPUBIC CATHETER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code KOB·August 23, 2022

COOK COPE-LOOP CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code LJE·March 17, 2022

COOK COPE-LOOP CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code LJE·March 17, 2022

COOK COPE-LOOP CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code LJE·March 17, 2022

COOK COPE-LOOP CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code LJE·March 17, 2022

COOK COPE-LOOP CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code LJE·August 23, 2021

COOK COPE-LOOP CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code LJE·July 21, 2021

Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

FDA Enforcement
Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023

TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems·October 10, 2018