BEUDAMED
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    CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·09010782023020·CC/ Gingiva GN neutral

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099716·MD MLR BDS R/L SE ASIA ASST100

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·ECWG0015971·CC/ Gingiva GN neutral 15g

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001597·artVeneer life upper anteriors, BXL, BL3

    RADIATION THERAPY RECORD AND VERIFY SYSTEM

    FDA Adverse Event
    Malfunction ·IMPAC, INC.·Product code IYE·April 14, 1994

    VITA RESPONSE

    FDA 510(k)
    FDA Class 2 ·Dental

    ACTIVE ARRAY CATHETER, MODEL CS-2000

    FDA 510(k)
    FDA Class 2 ·Radiology

    TOTAL ASR FEM IMP SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·March 13, 2013

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code NJE·February 25, 2011

    EUFLEXXA

    FDA Adverse Event
    Injury ·BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.·Product code MOZ·July 23, 2014

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    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