10 results
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25ms
·
Sources: EU EUDAMED, US FDA
X-RAY FILM PROCESSOR
FDA 510(k)
FDA Class 2
·Radiology
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981203283·Interbody, 9mm x 40mm x 11mm, 20 deg
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981195298·Interbody, 9mm x 40mm x 11mm, 20 deg
Arthrex®
FDA UDI
ARTHREX, INC.·00888867060319·ECLIPSE & UNIVERS II RESECT GD L,LFT
CA 125 II CALSET II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
CONSTELLATION
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 22, 2010
36MM COCR MOD HD STD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·July 17, 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