7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PREMIER(TM) H. PYLORY
FDA 510(k)
FDA Class 1
·Microbiology
IAS ANESTHESIA MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
INFILTUBE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GLV EXAM PF THIN NITRILE FINGER TEX MD
FDA Adverse Event
Injury
·CARDINAL HEALTH·Product code LZA·February 6, 2013
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·December 10, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 21, 2014
PKG, PKG, HOOK SCISSORS, P/N 0250080260. 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