BEUDAMED
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    PuraStat

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

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694023221·FPS 3.5/4.0mm 6mm Step Plate

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122315·KWire .094 x 9" (2.4x225mm)

    Ophthalmic Scissors

    FDA UDI
    KATENA PRODUCTS, INC.·00841668105269·SHEPARD-CASTROVIEJO SCISSORS

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517110777·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694077965·FPS 3.5/4.0 6mm Step Plate Sterile Qty 2

    Dermatological Carbon Dioxide Laser Systems

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

    SENSATOUCH

    FDA 510(k)
    FDA Class 2 ·Radiology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 21, 2021

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·February 26, 2020

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·March 5, 2020

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 15, 2026

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    GMK-SPHERE 02.12.E0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R E-CROSS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 13, 2023

    MATRIX2 STANDARD 360 SR COIL

    FDA Adverse Event
    Injury ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION·Product code HCG·November 19, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    CELLEX

    FDA Adverse Event
    Malfunction ·THERAKOS,INC.·Product code LNR·July 8, 2013

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·March 17, 2019

    SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018