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    Opus KSD, Inc.

    FDA registration
    Opus KSD, Inc.·2 products·🇺🇸 United States

    SubQ It! Bioabsorbable Skin Closure System

    FDA UDI
    OPUS KSD, INC.·00867469000220·SubQ It! Bioabsorbable Driver SU-10 is a single...

    SubQ It!

    FDA UDI
    OPUS KSD, INC.·00867469000206·SubQ It! Bioabsorbable Skin Closure System cons...

    SubQ It! Bioabsorbable Skin Closure System

    FDA UDI
    OPUS KSD, INC.·00867469000237·SubQ It! Bioabsorbable Driver SU-10 is a single...

    SubQ It! Bioabsorbable Skin Closure System

    FDA UDI
    OPUS KSD, INC.·00867469000244·SubQ It! Bioabsorbable Driver SU-25 is a single...

    SubQ It!

    FDA UDI
    OPUS KSD, INC.·00867469000213·SubQ It! Bioabsorbable Skin Closure SF10 is a s...

    ARROW

    FDA UDI
    TELEFLEX INCORPORATED·10801902219630·Arterial Catheterization Kit

    TMC HAND STRIPPER

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code KSD·August 18, 2011

    QUICK RX

    FDA Adverse Event
    Malfunction ·QUICK RX·Product code KSD·November 3, 2003

    HEMATRON III

    FDA Adverse Event
    Injury ·CONROY MEDICAL AB·Product code KSD·August 29, 2002

    HANDYSEAL

    FDA Adverse Event
    Injury ·CONROY MEDICAL AB·Product code KSD·July 9, 2002

    HANDYSEAL

    FDA Adverse Event
    Injury ·CONROY MEDICAL AB·Product code KSD·July 4, 2002

    HANDLYSEAL

    FDA Adverse Event
    Injury ·CONROY MEDICAL AB·Product code KSD·September 26, 2002

    *

    FDA Adverse Event
    Death ·ALCO INDUSTRIES·Product code KSD·September 9, 2009

    TSCD

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORP.·Product code KSD·October 26, 1999

    PPL SEALER

    FDA Adverse Event
    TERUMO BCT·Product code KSD·September 20, 2012

    T-SEAL II

    FDA Adverse Event
    Malfunction ·TERUMO BCT EUROPE N.V.·Product code KSD·December 20, 2016

    Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS; (5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID; (6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC; (7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA; (8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD; (9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL; (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS; (11) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3; (12) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH; (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL; (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.

    FDA Enforcement
    Class II ·Ongoing·ARROW INTERNATIONAL Inc.·October 2, 2024

    2380 MINI Hand-Held Tube Sealer Power Source (including a 23802000 Battery Pack) The Model 2380 Power Source is an instrument that generates RF power for making seals on tubing made of RF reactive thermoplastic materials typically used in blood banks, blood processing facilities and transfusion centers.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code KSD·January 31, 2011

    Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS; (5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID; (6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC; (7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA; (8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD; (9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL; (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS; (11) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3; (12) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH; (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL; (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL Inc.·Product code DQX·July 26, 2024