8 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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Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
FDA 510(k)
FDA Class 1
·General Hospital
LZI Fentanyl II Enzyme Immunoassay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GEL MARK III BIOPSY SITE MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD AUTOSHIELD DUO PEN NEEDLE 30GA 5MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 9, 2020
PSX INTERBODY SYSTEM
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code MAX·April 29, 2025
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 1, 2011
SETROX S 53
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·November 6, 2014
PARIETEX UGYTEX PP ANTERIOR KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTP·July 11, 2013