BEUDAMED
    21 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.

    FDA Enforcement
    Class II ·Terminated·Cellestis Inc·March 6, 2013

    Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs in total. Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.

    FDA Enforcement
    Class II ·Terminated·Cellestis Inc·March 6, 2013

    QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·March 30, 2016

    CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.

    FDA Enforcement
    Class II ·Terminated·Carefusion 2200 Inc·October 1, 2014

    TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK, Item No. 42582-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    4 Port "ON" Manifold (600 psi) w/4 ft. Transpac¿ IV, Item No. 46300-14NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    4 Port "ON" Manifold (600 psi) w/4 ft. Transpac¿ IV, Item No. 46300-14NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK WITHOUT COVERS, Item No. 42663-01NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND 1 WAY FM-FM STOPCOCK, Item No. 46104-35 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010, c) DLP¿ 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003, d) DLP¿ 38.1 cm (15 in) Multiple Perfusion Set, Model Number 14000, e) DLP¿ 50.8 cm (20 in) Extension Line Adapter, Model Number 11001G, f) DLP¿ Perfusion/Venting Adapter, Model Number 13002, g) DLP¿ Y Adapter Coronary Perfusion, Model Number 10710

    FDA Enforcement
    Class II ·Ongoing·Medtronic Perfusion Systems·May 22, 2024

    Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.

    FDA Enforcement
    Class II ·Terminated·Quest Medical, Inc.·December 9, 2015