10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ATRIUM PLASMA TFE SYNTHETIC ARTERY
FDA 510(k)
FDA Class 2
·Cardiovascular
Stainless Steel Wire
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746047817·WIRE SS LOWER 017 X 022 BONWILL HAWLEY 10/PK
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209122363·KIT, INDIVIDUAL FIRST AID - CUSTOM
Corin TaperFit Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRON PROTRUSIO CUP
FDA 510(k)
FDA Class 2
·Orthopedic
SPIRAL BLADE INSERTER FOR HINDFOOT ARTHRODESIS NAIL-EX
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·March 3, 2021
INRATIO PT/INR TEST STRIP
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·April 10, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·December 3, 2012
REPAIR CORE SABER DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·August 30, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024