11 results
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17ms
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Sources: EU EUDAMED, US FDA
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