12 results
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34ms
·
Sources: EU EUDAMED, US FDA
BIOSCAN REAGENT STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NA
FDA UDI
Stryker GmbH·04546540708410·Instrument Insert
Arthrex®
FDA UDI
ARTHREX, INC.·00888867060142·ECLIPSE DRILL TEMPLATE, SIZE 43
Titan™
FDA UDI
Ascension Orthopedics, Inc.·10381780246633·Titan™ Total Shoulder System
Round Mini Glenoid...
Titan™
FDA UDI
Ascension Orthopedics, Inc.·10381780246640·Titan™ Total Shoulder System
Oval Mini Glenoid ...
Titan™
FDA UDI
Ascension Orthopedics, Inc.·10381780246657·Titan™ Total Shoulder System
Oval Mini Glenoid ...
NDX-40 ALLOY
FDA 510(k)
FDA Class 2
·Dental
DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
INTEGRATED APD SET W/CASSETTE3 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 29, 2010
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·February 1, 2013
SYMPHONY
FDA Adverse Event
Injury
·SORIN CRM·Product code NVZ·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