72 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Uterine ElevatOR PRO with OccludOR Balloon
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540353696·SCREWDRIVER BLADE, CROSS-PIN
36M - Salt River Project-31 - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588022024·36M - Salt River Project-31 - Metal
OsteoMed
FDA UDI
OSTEOMED LLC·00845694007474·1.6mm Fast Flap Plate Organizer (II)
PLAYTEX DEODORANT TAMPONS, MODEL 34702
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EON CHOLESTEROL REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 8, 2023
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 8, 2023
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 3, 2014
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTL LTD·Product code KWA·August 15, 2011
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·December 1, 2023
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Injury
·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·February 16, 2024
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FPA·November 14, 2023
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Injury
·BECTON, DICKINSON & CO., (BD)·Product code FPA·December 28, 2023
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FPA·March 18, 2024
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FPA·March 22, 2024