9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SIMEOX 200 Airway Clearance Device
FDA 510(k)
FDA Class 2
·Anesthesiology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074494203·CD HORIZON SPIRE - INNER TRAY
V-Print splint
FDA 510(k)
FDA Unclassified
·Unknown
RAYSERT PLUS INJECTOR
FDA 510(k)
FDA Class 1
·Ophthalmic
BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·April 29, 2025
ENDOPOUCH RETRIEVER SPEC BAG
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC·Product code GCJ·November 21, 2008
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·August 16, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 22, 2013
PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233. 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