BEUDAMED
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    Filters Regulation: Us FDA ×

    SOFIA 88 Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HAWKEYE™ Vertebral Body Replacement (VBR)

    FDA UDI
    Choice Spine, LP·00840996100830·VBR,SPACER,12X14X24,0 DEG

    24M - Jackson EMC - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588140247·24M - Jackson EMC - Metal

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694020589·FPS 4.0mm x 24mm Standard Screw

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551113713·HALO, CTLSO VEST SMALL, ACRYLIC LINER, 1211-1 S...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694074827·FPS 4.0 x 24mm Screw Sterile Qty 2

    MODIFICATION TO ALPHA DX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    APD LUER-LOCK ADAPTER

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

    GLOBAL SHD HYL PEG GLENOID 48

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HRY·October 27, 2008

    ISYMM ASPHERIC INTRAOCULAR LENS

    FDA Adverse Event
    Other ·HOYA SURGICAL OPTICS INC.·Product code HQL·August 3, 2011

    SMALL PERIPHERAL CUTTING BALLOON?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·July 9, 2013

    UROSKOP Omnia Max. Model Number: 10762473

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·June 25, 2025

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 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.·May 3, 2017

    ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·July 19, 2017