14 results · 37ms · 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.

Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider

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

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197051132·Bengolea Hemostatic Forceps 26.0 c...

AUVON RECHARGEABLE TENS UNIT MUSCLE STIMULATOR

FDA Adverse Event
Injury ·SHENZHEN AS-TEC TECHNOLOGY CO., LTD·Product code NGX·January 27, 2025

VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE

FDA 510(k)
FDA Class 2 ·Cardiovascular

ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY

FDA 510(k)
FDA Unclassified ·Unknown

TENDRIL ST

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 13, 2014

ACCU-CHEK ® MOBILE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 3, 2013

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·June 28, 2011

AUVON TENS UNIT

FDA Adverse Event
Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024

VGXP XP INLK PRI TIB TRAY 73MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code MBH·August 12, 2016

MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.

FDA Enforcement
Class II ·Terminated·Philips Electronics North America Corporation·August 10, 2016

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021

Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

FDA Enforcement
Class II ·Terminated·Philips North America, LLC·March 25, 2020