10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665586247·MIS Cannulated Screw M, Ø5.5 x 50mm, Ø5.5mm Rod
Ophthalmic Scissors
FDA UDI
KATENA PRODUCTS, INC.·00841668105764·SCIMECA LOOP AMPUTATOR RIGHT
MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·August 31, 2011
ADAPTER SLEEVES 12/14 +5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 6, 2013
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 4, 2011
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 2, 2014
PKG, COBRA FORCEPS, P/N 0250080317. 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