BEUDAMED
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    FASTPACK TSH IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Bur PM2-70 80K diam EC Ø2.5 St

    FDA UDI
    Bien-Air Surgery SA·17630055519815·

    Aequalis™ Adjustable Reversed

    FDA UDI
    TORNIER, INC.·00846832068128·

    ILIZAROV

    FDA UDI
    Smith & Nephew, Inc.·03596010030665·2 HOLE MALE POST FOR SMALL BONE FIXATOR

    Oticon

    FDA UDI
    Oticon A/S·05707131163745·K14, MINIRITE SIL

    BIOMET 360 KNEE SYSTEM OFFSET ADAPTOR WITH SCREWS

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 6, 2019

    BIOMET KNEE SYSTEM SPLINED KNEE STEM V2 WITH SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 6, 2019

    BIOMET SPLINED KNEE STEM V2

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 6, 2019

    Zavation

    FDA UDI
    Zavation LLC·00197157010096·9.0mm TAP, CANNULATED, NAVLOCK

    BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 19, 2014

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·May 24, 2011

    GALAXY G3 6MM X 15CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·January 17, 2023

    GALAXY G3 XSFT 3MM X 6CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·January 17, 2023

    GALAXY G3 4MM X 12CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·January 17, 2023

    INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015