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

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MS-2 IDENTIFICATION SYSTEM

FDA 510(k)
FDA Class 1 ·Microbiology

EasyTouch

FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18023091·

ACUMED

FDA UDI
Acumed LLC·10806378096860·Small Reduction Forceps w/ Serrated Jaw

Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System

FDA 510(k)
FDA Class 2 ·Orthopedic

CAMBRIA

FDA 510(k)
FDA Class 2 ·Orthopedic

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·May 9, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 24, 2012

UNKNOWN DEPUY FEMORAL HEAD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·August 10, 2010

GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017