21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Capillus82
FDA 510(k)
FDA Class 2
·Physical Medicine
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837088460·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321515160·
TRABECULAR METAL REVISION SHELL LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
NMR LIPOPROFILE (R) TEST AND NMR PROFILER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code NAY·January 11, 2019
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code NAY·January 11, 2019
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code OLO·March 13, 2019
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·October 8, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·June 7, 2013
COULTER AC-T DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·June 24, 2011
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code OLO·April 10, 2019
ROSA ONE
FDA Adverse Event
Injury
·MEDTECH SA·Product code OLO·February 22, 2019
ROSA ONE
FDA Adverse Event
Injury
·MEDTECH SA·Product code OLO·March 11, 2019
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code NAY·April 3, 2019
ENDOSKELETON® TCS NO 6 SWIVEL DRIVER
FDA Adverse Event
Malfunction
·TITAN SPINE, LLC·Product code HXX·January 28, 2016
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019
Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. Component: The deformation occurs between the bolt and the fork in the joint connecting the lifting bar and the arm on the Molift Mover.
FDA Enforcement
Class II
·Ongoing·ETAC A/S·February 11, 2026
Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. Component: The deformation occurs between the bolt and the fork in the joint connecting the lifting bar and the arm on the Molift Mover.
FDA Recall
Open, Classified
·ETAC A/S Parallelvej 3 Gedved Denmark·Product code FSA·November 17, 2025