9 results
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36ms
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Sources: EU EUDAMED, US FDA
GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]
FDA 510(k)
FDA Class 1
·General Hospital
Temporary Abutment
FDA UDI
BICON, LLC·00813110029614·4.0 x 4.5mm Scannable Temporary Abutment - 2.5m...
Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Firefly Needleless Connector
FDA 510(k)
FDA Class 2
·General Hospital
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 9, 2023
SUREFIRE SCORPION
FDA Adverse Event
Malfunction
·ARTHREX ARTHROSCOPY INSTRUMENTS, INC.·Product code GAB·November 19, 2008
DUROM ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWA·August 25, 2011
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·July 23, 2013
PKG, 5MM X 45CM, INSERT, PERITONEAL SCISSORS, P/N 0250080751 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