11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MR Contour DL
FDA 510(k)
FDA Class 2
·Radiology
LEONE SPA
FDA UDI
LEONE SPA·08033707061694·BRACKETS 22 HIGH WING T-22 BIC LOWER
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122315·KWire .094 x 9" (2.4x225mm)
Burr
FDA UDI
KATENA PRODUCTS, INC.·00841668113158·DIAMOND BURR 5.0MM DIAMETER BALL
KARL STORZ ICG Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Surgical Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GLIDEWELL HT IMPLANT Ø4.3 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 29, 2025
TUBE, GASTROINTESTINAL (AND ACCESS)
FDA Adverse Event
Injury
·C.R BARD, INC. (BASD)·Product code KGC·November 21, 2008
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
ZIMMER CORTICAL SCREW SELF-TAPPING
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HWC·July 19, 2013
PKG, 5MM, 45CM, INSERT, DORSEY GRASPER FORCEPS, P/N 0250080736 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