11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDTRONIC INTERVENTIONAL VASCULAR Y-ADAPTER, TRI-ADAPTER, TRI-ADAPTER & ACCESSORY PACKS
FDA 510(k)
FDA Class 2
·Cardiovascular
AXSOS
FDA UDI
Stryker GmbH·07613327007688·Screw Tray w,o Racks ,4 and 5mm
INSPEKTOR PRO
FDA 510(k)
FDA Class 2
·Dental
EQUINOXE EXTRA SHORT HUMERAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 26, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 6, 2019
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
INVAMEX·Product code FSA·February 1, 2013
ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code MPA·December 22, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2014
EQUINOXE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·January 9, 2024
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