31 results · 21ms · Sources: EU EUDAMED, 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