18 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG
FDA 510(k)
FDA Class 2
·Neurology
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014
CoRoent
FDA UDI
Nuvasive, Inc.·00887517376664·CoRoent® Small Contoured, S8
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994617781·LID 1850108 SCREW CADDY LID
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00148501080·
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981123963·14x13x8mm, 7 Degree, No Profile Integrated Spacer
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515223417·Obwegeser Mandibular Peri Stripper, 5mm, 8"
TerraQuant
FDA UDI
Multi Radiance Medical·00852556007138·
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·00889981123966·No Profile Spacer, 14x13x8mm, 7 Degree, Sterile
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011850108000·Standard Band, Tooth 13/23, Size 8
Reverse Medical Micro Vascular Plug System
FDA 510(k)
FDA Class 2
·Cardiovascular
SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 4, 2014
HT70 VENTILATOR
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS·Product code CBK·November 27, 2012
TOTALCARE PULMONARY SURFACE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·September 28, 2010
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
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