31 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OrthoButton AL
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517292773·CoRoent® XLFW, 10x22x60mm Lordotic
MocareHealth
FDA UDI
Shanghai Motex Healthcare Co.,Ltd.·06930518031729·Natural Rubber Latex Surgical Gloves, Powder-Fr...
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100745·FLIERINGA RINGS SET OF 8
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100776·FLIERINGA FIXATION RING 16MM
NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)
FDA 510(k)
FDA Class 1
·General Hospital
SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BIZACT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·June 18, 2019
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 14, 2014
DA VINCI S SURGICAL SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL,INC.·Product code NAY·June 14, 2013
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·June 30, 2011
Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.
FDA Enforcement
Class II
·Terminated·SpineFrontier, Inc.·August 14, 2013
LATITUDE ELBOW ANATOMIC HUMERAL SPOOL SZ PETIT+ SIDE DROIT
FDA Adverse Event
Injury
·TORNIER INC·Product code JDB·September 20, 2024
BIZACT
FDA Adverse Event
Malfunction
·COVIDIEN MFG DC BOULDER·Product code GEI·April 30, 2024
BIZACT
FDA Adverse Event
Malfunction
·COVIDIEN MFG DC BOULDER·Product code GEI·April 30, 2024
BIZACT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·October 19, 2020
BIZACT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·October 19, 2020
BIZACT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·October 19, 2020
BIZACT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·October 21, 2020
BIZACT
FDA Adverse Event
Malfunction
·COVIDIEN MFG DC BOULDER·Product code GEI·April 30, 2024