12 results
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21ms
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Sources: EU EUDAMED, US FDA
CAMERA COVER WITH TEAR TIP
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
AXSOS
FDA UDI
Stryker GmbH·07613327089257·Plate Insert with tag Proximal Lateral Tibia
PROFYLE
FDA UDI
Stryker GmbH·04546540363893·1.7mm Implant Module
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981195458·Interbody, 9mm x 40mm x 15mm, 20 deg
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981203443·Interbody, 9mm x 40mm x 15mm, 20 deg
FERRIS VENT-A-DERM
FDA 510(k)BONE CEMENT FOR CRANIOPLASTY
FDA 510(k)
FDA Class 2
·Neurology
CRUCIFORM SCREWDRIVER
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·October 25, 2019
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
TERUMO CENTRIFUGAL SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWA·December 23, 2010
UNK MAMMARY IMPLANT
FDA Adverse Event
Injury
·ALLERGAN·Product code FWM·March 21, 2014
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