8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
LIMITED MOTION FUNCTIONAL KNEE BRACE
FDA 510(k)
FDA Class 1
·Physical Medicine
Easter S.L Bracket, .022 Roth, LR4, w/o hook
FDA UDI
Astar Orthodontics Inc.·06941673516204·
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 23, 2014
SCORPIO NRG X3 PS TIBIAL INSERT #5 10MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·November 2, 2012
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MPW·September 7, 2010
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024