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    Spark Biomedical Inc.

    FDA registration
    Spark Biomedical Inc.·1 product·🇺🇸 United States

    Sparrow Ascent Cable

    FDA UDI
    Spark Biomedical Inc.·00860005396979·The Sparrow Ascent Cable is 37 inches long and ...

    Sparrow Ascent Earpiece, Right

    FDA UDI
    Spark Biomedical Inc.·00850052017019·The Earpiece is a disposable component of the S...

    Sparrow Ascent Patient Controller

    FDA UDI
    Spark Biomedical Inc.·00860005396955·The Sparrow Ascent Patient Controller is a tran...

    Sparrow Ascent 28 Piece Kit (B2C)

    FDA UDI
    Spark Biomedical Inc.·00850052017088·A starter pack with all the components for acut...

    Sparrow Ascent Kit (B2C)

    FDA UDI
    Spark Biomedical Inc.·00860005396948·The Sparrow Ascent is a transcutaneous auricula...

    Sparrow Ascent

    FDA UDI
    Spark Biomedical Inc.·00850052017552·Sparrow Ascent Kit - B2C (Mastoid Left 7)

    Sparrow Ascent 28 Piece Kit (B2B)

    FDA UDI
    Spark Biomedical Inc.·00850052017071·A starter pack with all the components for acut...

    Sparrow Ascent Kit (B2B)

    FDA UDI
    Spark Biomedical Inc.·00860005396986·The Sparrow Ascent is a transcutaneous auricula...

    Sparrow Ascent Replacement Kit

    FDA UDI
    Spark Biomedical Inc.·00850052017033·Separate item for replacement. The Sparrow Asce...

    Sparrow Ascent Cable

    FDA UDI
    Spark Biomedical Inc.·00850052017040·The Sparrow Ascent Cable is 37 inches long and ...

    Sparrow Ascent Earpiece, Left

    FDA UDI
    Spark Biomedical Inc.·00860005396962·The Earpiece is a disposable component of the S...

    Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28

    FDA Recall
    Open, Classified ·Spark Biomedical Inc·Product code PZR·July 2, 2025

    Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28

    FDA Enforcement
    Class II ·Ongoing·Spark Biomedical Inc·August 20, 2025

    HF-CABLE, MONOPOLAR

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCJ·December 9, 2021

    Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number 21-2145-01 only for use with Smiths Medical CADD-Solis ambulatory infusion pumps, Model 2100. These cords were sold as an accessory for these pumps under Manufacturing Number A23.164.098.0A, Electri-Cord part Number PC2000403. Electri-Cord AC Power Cords are accessories for use with the CADD-Solis Ambulatory Infusion Pump. These power cords allow users to run the pump via AC power rather than battery power. The CADD-Solis pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code MEA·January 27, 2010

    Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. Model #(s): Individual Patient Circuit - catalog # 902 Patient Circuit Kit - catalog # 937: contains 2 circuits and 2 x 2.5 & 2 x 3.5 LifePort Adapters. Labeling states manufactured by: Bunnell Incorporated 436 Lawndale Drive, Salt Lake City, Utah 84115. Used for ventilating critically ill infants with pulmonary interstitial emphysema and infants with respiratory distress syndrome complicated by pulmonary air leaks, who are, in the opinion of their physicians, failing on conventional ventilation. The Patient Circuit is to provide a conduit for the humidification, warming, and temperature monitoring of the pressurized gas. The Patient Circuit is indicated for seven day single use.

    FDA Recall
    Terminated ·Bunnell, Inc.·Product code LSZ·November 19, 2012

    MDSS GmbH

    Authorized representative
    🇩🇪 Germany·388 Manufacturers·16562 Devices

    28CM ALTA EXCHANGE KIT Model: AL23SH28 XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free.

    FDA Recall
    Terminated ·Spire Biomedical, Inc. One Patriots Park·Product code MSD·October 23, 2009

    40CM DECATHLON GOLD STD KIT Models: DEC35SH40 and DEC35SH40-K DECATHLON GOLD 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.

    FDA Recall
    Terminated ·Spire Biomedical, Inc. One Patriots Park·Product code MSD·October 23, 2009