10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs)
FDA 510(k)
FDA Class 1
·General Hospital
THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ELVIS HSV ID AND D3 TYPING TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 28, 2015
TENDRIL ST
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·January 13, 2014
AUTOPULSE¿ RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·June 26, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·July 28, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·August 19, 2015
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