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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    AxTiHA® Stand-Alone ALIF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464092031·OTICON JET 1 MINIRITE C063

    Good Works

    FDA UDI
    Bosma Enterprises·00818634025340·Good Works Performance Pro Large 100/Box

    Good Works

    FDA UDI
    Bosma Enterprises·00818634025555·Good Works AN Performance Pro Large 100/Box

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306806049·Clinton Extra-Long Pederson-Style Speculum, 15....

    ABSORBENT PAPER POINTS

    FDA UDI
    DiaDent Group International·08806383516365·"An absorbent paper points is an endodontic pap...

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011250603200·ceraMotion® Zr 3D Dentin CC2-1, 20 g / dental c...

    Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OLPUR DIALYZER, MODEL HD 190

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·November 14, 2008

    FLEX 60 ENDO

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 16, 2011

    GYNECARE TVT OBTURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 26, 2013

    Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601

    FDA Enforcement
    Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

    Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603

    FDA Enforcement
    Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

    Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602

    FDA Enforcement
    Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

    Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373

    FDA Enforcement
    Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

    NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.

    FDA Enforcement
    Class II ·Completed·Applied Medical Technology Inc·October 15, 2025

    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

    Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 28, 2026