BEUDAMED
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    Flexible Block

    FDA 510(k)
    FDA Class 2 ·Dental

    MODULUS-STRUM. - ESTRATTORE CO

    FDA Adverse Event
    Malfunction ·LIMACORPORATE S.P.A.·Product code KWY·July 18, 2019

    DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MODIFICATION TO VIEWSEND MEDICAL

    FDA 510(k)
    FDA Class 2 ·Radiology

    VIDEO MEDIASTINOSCOPE

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

    VIDEO MEDIASTINOSCOPE

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

    VIDEO MEDIASTINOSCOPE

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

    VIDEO MEDIASTINOSCOPE

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYG·October 20, 2008

    LACTO SCR 2.0X7MM 2.0 SYS 2/PK

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·August 17, 2011

    12/14 ARTICUL 40MM M SPEC-2

    FDA Adverse Event
    Injury ·8010379 DEPUY INTL., LTD.·Product code LPH·July 9, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·February 22, 2024

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025