61 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA
FDA 510(k)
FDA Class 2
·Cardiovascular
JOBST Bella Strong
FDA UDI
BSN MEDICAL, INC.·00035664010669·BSTRNG 30-40 ARMSLV DOT BAND 10R NAT 1 E
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L102420120·10mm H x 24mm W x 20mm L XLIF Trial 12 degree L...
Precision MIS Bunion System
FDA UDI
Paragon 28, Inc.·00889795132550·Ø2.4mm Cannulated Drill for Ø3.0 Screw, Long
Viceroy
FDA UDI
DIOMEDICAL CO.,LTD.·08800113904958·VICEROY Rod - 5.5 (D)5.5x(L)420mm
HITACHI ALTAIRE
FDA 510(k)
FDA Class 2
·Radiology
PHILIPS OBTRACEVUE MODEL SW REV. G.00
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·April 17, 2018
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·October 7, 2020
LIGASURE
FDA Adverse Event
Injury
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·July 21, 2018
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·February 20, 2018
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·November 26, 2018
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·June 9, 2021
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·February 2, 2018
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·November 13, 2018
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·April 16, 2019
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MFG DC BOULDER·Product code GEI·April 24, 2020
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MFG DC BOULDER·Product code GEI·March 14, 2019
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·June 16, 2021
TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·September 5, 2012