13 results
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21ms
·
Sources: EU EUDAMED, US FDA
Fast Warm - NX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813058084·STERILE CARBIDE BUR FG245 DARBY
Oticon
FDA UDI
Sbo Hearing A/S·05714464089963·OTICON JET 1 BTE PP C092
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250445050·ceraMotion® PZr Ingot D3, 5 x 2 g / dental cera...
AMS COLLAGEN DERMAL MATRIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNCARDIA COMPANION 2 DRIVER
FDA Adverse Event
Malfunction
·SYNCARDIA SYSTEMS, INC.·Product code LOZ·November 7, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011
SCREW CORTICAL 3.5X14MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HRS·July 26, 2013
ASAHI GLADIUS EX
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·September 17, 2025
BD INTIMA-II 20GAX1.16IN PRN SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·February 6, 2024
ASAHI GLADIUS EX
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·April 13, 2026
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024