7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VISISTAT SKIN STAPLING DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET
FDA 510(k)RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·February 5, 2013
CONTAK RENEWAL
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 3, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·July 18, 2014
PKG, BLUNT FORCEPS, BLUNT, SERRATED, SPOON, P/N 0250080313. 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. 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