14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEGA BIG BOY CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RANDOX IMMUNOASSAY CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 25, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 9, 2011
OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·TRIVASCULAR, INC.·Product code MIH·July 18, 2013
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·September 25, 2024
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·July 13, 2023
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·May 23, 2024
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·June 7, 2024
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·November 28, 2024
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·October 31, 2023
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025