BEUDAMED
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    Solas OR

    FDA 510(k)
    FDA Class 2 ·Radiology

    ABSORBENT PAPER POINTS

    FDA UDI
    DiaDent Group International·08806383515337·"An absorbent paper points is an endodontic pap...

    CERALAS D DIODE LASER SYSTEM, MODEL # D50

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COBAS® MPX - 96T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 26, 2025

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·August 16, 2011

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    FDA Adverse Event
    Malfunction ·MINNTECH CORPORATION·Product code FEB·October 23, 2008

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 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