10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304233072·
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PACSMATE MMD-5201M MONITOR
FDA 510(k)
FDA Class 2
·Radiology
HAMILTON MEDICAL AG
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·August 30, 2023
TECNIS SYMFONY TORIC
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code POE·February 5, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
SENSOR ENLITE
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·October 4, 2014
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·June 27, 2011
PKG, KELLY FORCEPS, CURVED LEFT, P/N 0250080283. 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