9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARRIAZO BARRAQUER MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981741·anteriors; shade A3.5 light; mould US4
IceSphere 1.5 CX Cryoablation Needle
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUROLINK IP, MODEL PK1113
FDA 510(k)
FDA Class 2
·Neurology
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·February 8, 2011
FRS SCREW 12MM L X 2.5MM D
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HWC·August 5, 2014
640G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 27, 2016
ARCHITECT C16000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·May 10, 2019
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026