15 results
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24ms
·
Sources: EU EUDAMED, US FDA
ELECTRO INTERSTITIAL SCAN
FDA 510(k)
FDA Class 2
·Neurology
REPICCI II RESURFACING KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304009660·
Tray Pin 0-2
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215056599·
4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ
FDA 510(k)
FDA Class 2
·Radiology
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN)
FDA 510(k)
FDA Class 1
·General Hospital
GALAXY G3 MINI 1MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·June 19, 2020
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 9, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 20, 2011
ABBOTT AXSYM SYSTEM
FDA Adverse Event
Other
·ABBOTT LABORATORIES, INC.·Product code JJE·August 7, 2008
GALAXY G3 MINI 1MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·October 1, 2022
TRUETRACK
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·June 28, 2018
DEKA SMARTXIDE² TRIO
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 31, 2023
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025