12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)
FDA 510(k)
FDA Class 2
·Radiology
Artman Instruments
FDA UDI
Wise Linkers, LLC·D1272423941·Dental Crown Splitter Remover & Elevator ARTMAN
LEONE SPA
FDA UDI
LEONE SPA·08033707041108·ROTH DB BRACKET 22 KIT
Masimo Root Monitoring System and Accesories
FDA 510(k)
FDA Class 2
·Cardiovascular
DIAGNODENT PERIO TIP (ACCESSORY)
FDA 510(k)
FDA Class 2
·Dental
RADIUS-7
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·July 2, 2015
INTERLOCK?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRD·November 11, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 10, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 23, 2013
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. 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