9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
AXSOS
FDA UDI
Stryker GmbH·07613327294330·Lid for Screw Caddy 2.7mm
SpiritMB
FDA UDI
ORMCO CORPORATION·00889989007107·ID V - Twin - Lower-Left Cuspid - Purple
DUCERAGOLD PORCELAINS
FDA 510(k)
FDA Class 2
·Dental
ULNAR NERVE PROTECTOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 17, 2014
3 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 9, 2010
EXTERNAL NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·February 3, 2013
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020