BEUDAMED
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    RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    COMPLETE BRAND LUBRICATING AND REWETTING DROPS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PORTEX SECUREEASY ENDOTRACHEAL TUBE HOLDER

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code CBH·March 11, 2013

    UNKNOWN ZIMMER CR FLEX FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·February 24, 2011

    BIOSREW BIOABSORBABLE INTERFERENCE SCREW 9MM

    FDA Adverse Event
    Malfunction ·CONMED LINVATEC·Product code MAI·February 25, 2008

    SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 42-15

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSD·June 26, 2018

    PEN NDL 29GA SHIELD BULK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·April 11, 2019

    SIDUS STEM-FREE SHOULDER, HUMERAL HEAD, 50-21

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSD·June 11, 2018

    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display 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 models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·October 1, 2014

    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

    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

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

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

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