9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BOSWORTH COPALIONER
FDA 510(k)
FDA Class 2
·Dental
SeaSpine Spacer System - Pacifica
FDA UDI
Seaspine Orthopedics Corporation·10889981089047·Pacifica Implant/Trial Caddy - 11mm x 24mm
RENACLEAN SH DIALYZER CLEANING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 29, 2013
FLEXICAP DISCONNECT CAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·December 20, 2010
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·July 14, 2014
BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·January 4, 2022
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-06-23, c) 44, 47, 50, 53 head, Large, Item Number 314-06-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-06-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024