57 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Athena III Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
HHM
FDA UDI
Sbo Hearing A/S·05714464029754·HHM F400 MINIRITE T C090
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780183747·Integra® Jarit® Liston Bone Cutting Forceps, 5-...
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573020652·INTRG WHISP-Z MBT CEN +17T +4A 022 UR
Vasomedical-Biox™ 2303 Combined 3 Channel ECG Holter & ABP Monitor
FDA UDI
VASOMEDICAL, INC.·00817980020092·3 CH ECG Holter/ABP COMBINED Recorder
UNICONDYLAR FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
T:FLEX INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·February 8, 2019
MEDFUSTION 3500 SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD, INC.·Product code FRN·October 21, 2014
UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·September 1, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 16, 2013
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025
AxioGlass
FDA UDI
Axiodent Inc.·D161230300·
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025
BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·March 5, 2025
BD MINIDRAW¿ FINGER SLEEVE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·February 27, 2025
BD MICROLANCE CONVENTIONAL NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·June 17, 2024
BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·August 6, 2024
BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 29, 2025
BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 29, 2025