17 results · 25ms · Sources: EU EUDAMED, US FDA

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ACENT™ Central Venous Catheter

FDA 510(k)
FDA Class 2 ·General Hospital

STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER

FDA 510(k)
FDA Class 1 ·Dental

ION MAGNUM GENIUS

FDA 510(k)
FDA Class 2 ·Physical Medicine

SURESTEP

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CGA·May 25, 2000

CLEARLINK PACLITAXEL SETS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·February 2, 2024

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 6, 2026

SEE H10

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 17, 2020

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

DUO-VENT CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 12, 2023

NI

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

FDA Adverse Event
Malfunction ·BIOENTERICS CORPORATION·Product code LTI·October 6, 2008

SPEEDLOCK IMPLANT WITH INSERTER HANDLE

FDA Adverse Event
Malfunction ·ARTHROCARE CORPORATION·Product code MBI·June 25, 2013

6800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 22, 2011

NI

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

FDA Enforcement
Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020