7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KleenGel Dispenser
FDA 510(k)
FDA Class 1
·General Hospital
CLEAFIL DC CORE AUTOMIX
FDA 510(k)
FDA Class 2
·Dental
COMPLETE D 25-OH VITAMIN D CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ROLLATOR
FDA Adverse Event
Injury
·MEDLINE INDUSTRIES, INC.·Product code ITJ·May 24, 2013
PHILIPS INTELLIVUE INFORMATION CENTER (PIIC) IX
FDA Adverse Event
Malfunction
·PHILLIPS MEDICAL SYSTEMS·Product code MHX·September 29, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Injury
·INVAMEX·Product code IOR·June 28, 2011
PKG, DEBANEY FORCEPS, P/N 0250080314. 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