8 results
·
35ms
·
Sources: EU EUDAMED, US FDA
ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS
FDA 510(k)
FDA Class 2
·Physical Medicine
SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POEDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 ?11X440MM X 1
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 20, 2012
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·January 18, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 9, 2014
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