9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Dental Glass Ceramics Blocks (HT, LT, MT)
FDA 510(k)
FDA Class 2
·Dental
Artman Instruments
FDA UDI
Wise Linkers, LLC·D1272424071·Bone Graft Implant Syringe 5 mm Curved ARTMAN B...
Straight Stud Attachment
FDA 510(k)
FDA Class 2
·Dental
EMIT CAFFEINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GLUCOSE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·November 21, 2008
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
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
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025