10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FASCOUNT SYSTME
FDA 510(k)
FDA Class 2
·Hematology
SeaSpine Spacer System - Pacifica
FDA UDI
Seaspine Orthopedics Corporation·10889981088880·Paddle Scraper, 16mm
GE PRECISION MPI
FDA 510(k)
FDA Class 2
·Radiology
STELLARIS PC VISION ENHANCEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
HEALON GV PRO
FDA Adverse Event
Injury
·AMO UPPSALA AB·Product code LZP·October 27, 2022
BD VACUTAINER® SINGLE USE HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·December 6, 2017
PINNACLE MTL INS NEUT36IDX62OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·January 29, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·December 20, 2010
SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·July 14, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024