BEUDAMED
    21 results · 27ms · Sources: EU EUDAMED, US FDA

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    Progreat Lambda

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551111030·HALO, 1203-5 VEST PED3, ACRYLIC LINER, 1211-1 X...

    Savant Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C41432110780·Titanium TLIF Spacer, 32 x 11 x 7mm, 8 deg

    Savant Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C40432110780·PEEK TLIF Spacer, 32 x 11 x 7mm, 8 deg

    CORTAC®

    FDA UDI
    PMT CORPORATION·00650551057253·SUBDURAL GRID ELECTRODE, PLATINUM, 78 CONTACT, ...

    CORTAC®

    FDA UDI
    PMT CORPORATION·00650551081821·SUBDURAL GRID ELECTRODE, PLATINUM, 78 CONTACT, ...

    MALLEABLE SHAFT CLAMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AEU-26L ELCTRONIC ENDODONTIC SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    EASYPOINT NEEDLE

    FDA Adverse Event
    Injury ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023

    EASYPOINT NEEDLE

    FDA Adverse Event
    Injury ·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023

    MINI-INFUSER RADIATION STERILIZED EXTENSION SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 7, 2021

    TALENT ABDOMINAL STENT GRAFT SYSTEM HYDRO

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·October 24, 2008

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 5, 2011

    THINLINE II

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·July 8, 2013

    Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·August 28, 2013

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 3, 2026

    Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 20, 2026

    Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper FD20 OR Table, Model Number: 722035. 7. Allura Xper FD20/20, Model Number: 722038 8. Allura Xper FD20/20 OR Table, Model Number: 722039. 9. Allura Xper FD20/15, Model Number: 722058. 10. Allura Xper FD20/15 OR Table, Model Number: 722059.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·August 6, 2025