12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
GenIQ
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517575142·CoRoent Ant TLIF Ti, 14x13x36mm 8°
AUVON RECHARGEABLE TENS UNIT MUSCLE STIMULATOR
FDA Adverse Event
Injury
·SHENZHEN AS-TEC TECHNOLOGY CO., LTD·Product code NGX·January 27, 2025
HAIRMAX LASERCOMB
FDA 510(k)
FDA Class 2
·Physical Medicine
VITELCARE TURTLE, MODEL 400
FDA 510(k)
FDA Class 2
·Cardiovascular
NOBLUS ULTRASOUND SCANNER
FDA Adverse Event
Malfunction
·Product code IYO·March 30, 2017
ROTALINK? PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MCX·October 6, 2014
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·May 24, 2013
CAPD DISCONNECT Y SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 29, 2011
AUVON TENS UNIT
FDA Adverse Event
Injury
·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·October 17, 2018
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