BEUDAMED
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    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06936735452279·Disposable SpO2 Sensor Nellcor Non-Oximax Compa...

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06945664876650·Disposable SpO2 Sensors Nellcor Compatible, Adh...

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06945664876407·Disposable SpO2 Sensors, Nellcor Compatible, Ad...

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06945664876391·Disposable SpO2 Sensors, Nellcor Compatible, Ad...

    APK

    FDA UDI
    APK Technology Co.,Ltd.·06946725535653·Disposable Nellcor Oximax Neonate

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06936735450824·Disposable SpO2 Sensors, Nellcor Compatible, Ad...

    APK

    FDA UDI
    APK Technology Co.,Ltd.·06946725535660·Disposable Nellcor Oximax Neonate

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06936735452255·Disposable SpO2 Sensor Nellcor Compatible, Infant

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06936735450831·Disposable SpO2 Sensors, Nellcor Compatible, Ad...

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06936735452262·Disposable SpO2 Sensor Nellcor Compatible, Pedi...

    CLARITY MONO TEST

    FDA Adverse Event
    Malfunction ·CLARITY DIAGNOSTICS LLC·Product code KTN·November 20, 2019

    CLARITY MONONUCLEOSIS RAPID TEST CASSETTE

    FDA Adverse Event
    Malfunction ·CLARITY DIAGNOSTICS LLC·Product code KTN·November 20, 2019

    CLARITY UROCHECK U120C URINE ANALYZER

    FDA Adverse Event
    Malfunction ·ACON LABORATORIES, INC.·Product code KQO·August 27, 2025

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06945664828482·SpO2 interface cable/Nellcor-Oximax/0.3M/103X+1...

    Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. The Clarity Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations, and are intended for professional use only. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas: kidney function, urinary tract infections, carbohydrate metabolism (e.g. diabetes mellitus), liver function, acid-base balance and urine concentration. The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The Clarity 10SG Urinalysis Reagent Strips (Urine) can be read visually , on the Clarity Urocheck 120 Urine Analyzers , and on the Clarity Urocheck 120C Urine Analyzers.

    FDA Enforcement
    Class III ·Terminated·Clarity Diagnostics Llc·August 22, 2018

    Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.

    FDA Enforcement
    Class I ·Terminated·Atossa Genetics, Inc.·November 6, 2013

    MEDTRONIC SLITTER

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DTG·October 13, 2021

    MAGNET, TEST, PACEMAKER

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DTG·August 5, 2015

    MAGNET, TEST, PACEMAKER

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTG·February 8, 2014

    MAGNET, TEST, PACEMAKER

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DTG·April 10, 2019