20 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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