BEUDAMED
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    CARDIOVISE ECG INTERPRETATIVE SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099693·MAN MLR BDS ASST 100 SE ASIA

    NIH™

    FDA UDI
    MEDTRONIC, INC.·00763000199227·WVN CATHETER 001349 10PK 5F 80CM NIH

    NIH™

    FDA UDI
    MEDTRONIC, INC.·00613994964403·WVN CATHETER 001349 10PK 5F 80CM NIH

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001349·artVeneer life upper anteriors, ITS, C2

    24M - Tampa Electric Co.

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588013497·24M Tampa Electric Co.

    MOTORIZED MICRO MULTILEAF COLLIMATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/17MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2024

    CONSERVE(R) PLUS CUP

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LZO·August 12, 2024

    GMK REVISION TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 2, 2025

    PENUMBRA SMART COIL DETACHMENT HANDLE

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·August 7, 2017

    PENUMBRA SMART COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·August 7, 2017

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 13, 2013

    PLASMABLADE TNA TISSUE DISSECTION DEVICE

    FDA Adverse Event
    Other ·PEAK SURGICAL INC.·Product code GEI·February 18, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC·Product code JAA·February 22, 2008

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    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

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024