20 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER
FDA 510(k)
FDA Class 2
·Orthopedic
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK)
FDA 510(k)
FDA Class 1
·General Hospital
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·October 22, 2018
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·October 22, 2018
LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·June 12, 2017
INSORB 30 STAPLER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GDW·December 17, 2019
LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·January 10, 2018
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·October 16, 2018
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 4, 2011
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code JDI·June 27, 2013
CLEARLINK SYSTEM BURETROL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FPA·October 10, 2014
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC.·Product code DRE·December 7, 2018
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·October 15, 2018
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·April 13, 2017
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·December 11, 2019
LEAD EXTRACTION EVOLUTION SHORTIE MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·March 22, 2017
LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·May 11, 2017
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021