15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE
FDA 510(k)
FDA Class 2
·Neurology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517376657·CoRoent® Small Contoured, S7
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994617798·LID 1850107 SCREW CADDY LID
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00148501070·
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981123956·14x13x7mm, 7 Degree, No Profile Integrated Spacer
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011850107000·Standard Band, Tooth 13/23, Size 7
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·00889981123959·No Profile Spacer, 14x13x7mm, 7 Degree, Sterile
Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
HARVARD 2 SYRINGE PUMP, MODEL 2001-001
FDA 510(k)
FDA Class 2
·General Hospital
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 4, 2014
EASYTRAK 2
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·October 1, 2010
HT70 VENTILATOR
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS·Product code CBK·November 27, 2012
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021