67 results · 21ms · Sources: EU EUDAMED, US FDA

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DESTINATION CAROTID GUIDING SHEATH

FDA 510(k)
FDA Class 2 ·Cardiovascular

Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

FDA Recall
Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

CEBOTOME

FDA UDI
Conmed Corporation·10845854006405·CEBOTOME ROUND BUR, 8 MM

NA

FDA UDI
STERILMED, INC.·10888551017855·BUR CEBOTOME ROUND

UNIVERSAL CMF SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 16, 2016

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPAEDIC INC.·Product code KWP·June 25, 2009

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWQ·July 23, 2009

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·August 30, 2013

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 5, 2025

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·June 27, 2017

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 16, 2016

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·December 23, 2011

CD HORIZON ADANTA

FDA Adverse Event
Other ·MEDTRONIC SOFAMOR DANEK·Product code KWP·April 3, 2009

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·June 27, 2017

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·June 27, 2017

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·November 28, 2019

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·January 6, 2021

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPER·Product code KWP·June 10, 2009