20 results · 27ms · Sources: EU EUDAMED, US FDA

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Neon EEG

FDA 510(k)
FDA Class 2 ·Neurology

ProLift Trial

FDA UDI
Life Spine, Inc.·00190837089009·

CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES

FDA 510(k)
FDA Class 2 ·Cardiovascular

AVANA DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

PENUMBRA SMART COIL

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code HCG·December 11, 2015

KRD DEVICE, EMBOLIZATION, VASCULAR

FDA Adverse Event
Malfunction ·COOK INC·Product code KRD·September 19, 2019

TITANIUM MATRIXRIB PRE-CONTOURED PL 16 HOLES FOR RIGHT RIBS 4 AND 5

FDA Adverse Event
Injury ·SYNTHES USA·Product code HRS·June 7, 2013

GORE TAG THORACIC ENDOPROSTHESIS

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code MIH·June 29, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

RETRACTA DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Injury ·COOK INC·Product code KRD·June 20, 2019

RETRACTA DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Malfunction ·COOK INC·Product code KRD·September 17, 2018

RETRACTA DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Malfunction ·COOK INC·Product code KRD·September 17, 2018

RETRACTA DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Malfunction ·COOK INC·Product code KRD·January 2, 2020

RETRACTA DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Malfunction ·COOK INC·Product code KRD·January 2, 2020

RETRACTA DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Malfunction ·COOK INC·Product code KRD·March 11, 2020

RETRACTA DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Malfunction ·COOK INC·Product code KRD·July 31, 2019

ENDOSKELETON® TCS NO 6 SWIVEL DRIVER

FDA Adverse Event
Malfunction ·TITAN SPINE, LLC·Product code HXX·January 28, 2016

RETRACTA DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Injury ·COOK INC·Product code KRD·February 25, 2019

RETRACTA DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Malfunction ·COOK INC·Product code KRD·February 3, 2020

IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

FDA Enforcement
Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019