14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IPL Hair Removal Device (BE932C, BE932D, BE932E)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SAPPHIRE ADMINISTRATION SET
FDA 510(k)
FDA Class 2
·General Hospital
ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM
FDA 510(k)
FDA Class 2
·Dental
AP409 -PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·December 18, 2025
AP205 - INFUSION SET WITH NON-VENTED SPIKE, 1.2UM FILTER AND NEEDLE Y-SITE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 5, 2024
AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 6, 2024
AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 17, 2024
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PML·February 26, 2026
AP403 - MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·March 31, 2026
AP407 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND NEEDLELESS Y-SITE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·March 4, 2026
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 10, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 22, 2013
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PML·November 13, 2025