BEUDAMED
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    BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS

    FDA 510(k)
    FDA Class 2 ·Immunology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814725·GENUMEDI EXTRA WIDE SAND SIZE IV

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857520547·Split Tube Retractor, Size Ø18x60 mm

    3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AGX

    FDA UDI
    Widex A/S·05706069748338·Audigy AGXWU-FM (Midnight black S-110 ) RC coil

    AGX

    FDA UDI
    Widex A/S·05706069749182·Audigy AGXWU-FP (Midnight black S-110 ) Telecoi...

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·February 3, 2022

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·May 10, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

    UNKNOWN ZIMMER HIP

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDI·May 24, 2011

    GALAXY G3 XSFT 3.5MM X 7.5CM

    FDA Adverse Event
    Injury ·CERENOVUS, INC.·Product code KRD·July 7, 2023

    GALAXY G3 4MM X 7CM

    FDA Adverse Event
    Injury ·CERENOVUS, INC.·Product code KRD·July 7, 2023

    GALAXY G3 XSFT 2MM X 2CM

    FDA Adverse Event
    Injury ·CERENOVUS, INC.·Product code KRD·July 7, 2023

    GALAXY G3 XSFT 3.5MM X 7.5CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·June 15, 2022

    GALAXY G3 XSFT 2MM X 2CM

    FDA Adverse Event
    Injury ·CERENOVUS, INC.·Product code KRD·July 7, 2023

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

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

    Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

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