503 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Anker Dental Implant System - SB-III, ST and AT series
FDA 510(k)
FDA Class 2
·Dental
MAT PLATFORM,HYDR,BLUE,5X7'
FDA UDI
Hausmann Enterprises, LLC·00840314804600·
MAT PLATFORM,HYDR,BLACK,5X7'
FDA UDI
Hausmann Enterprises, LLC·00840314804631·
MAT PLATFORM,HYDR,GREEN,5X7'
FDA UDI
Hausmann Enterprises, LLC·00840314804624·
MAT PLATFORM,HYDR,GRAY,5X7'
FDA UDI
Hausmann Enterprises, LLC·00840314804617·
INNOJECT AUTO-INJECTOR
FDA 510(k)
FDA Class 2
·General Hospital
NOVAKONE SPHERICAL AND TORIC LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
PELVICOL ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABS.·Product code FTL·April 11, 2013
TRIAGE PROFILER SOB 25 TEST KIT
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code MMI·June 20, 2011
MAYFIELD HEAD HOLDER
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·October 1, 2014
GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Death
·WILLIAM COOK EUROPE·Product code DTK·July 23, 2019
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·July 9, 2020
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·October 2, 2019
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·October 31, 2019
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·October 7, 2019
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·October 7, 2019
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·October 2, 2019
GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·February 5, 2021
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·December 5, 2019
PKG, 3MM INSERT, BIOPSY PUNCH, 20CM, P/N 0250282013 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014