7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III
FDA 510(k)
FDA Class 2
·Cardiovascular
Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)
FDA 510(k)
FDA Class 1
·General Hospital
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
FDA 510(k)
FDA Class 2
·Neurology
ACCURUS 800CS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 17, 2010
BASIC CONFIGURATION MODEL 6100 BASE
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·February 4, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 17, 2014
PKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, SINGLE ACTION, P/N 0250080584 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