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    Filters FDA Enforcement × Status: Terminated × Clear all

    Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·February 20, 2013

    Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·February 17, 2016

    216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·April 26, 2017

    Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.

    FDA Enforcement
    Class II ·Terminated·Mizuho OSI·October 21, 2020

    Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer

    FDA Enforcement
    Class I ·Terminated·ARROW INTERNATIONAL Inc.·December 21, 2022

    Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·October 7, 2015

    Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·October 22, 2014

    Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018

    Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018

    Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing

    FDA Enforcement
    Class III ·Terminated·Arrow International Inc·February 4, 2015

    Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS; ASK-45703-PGMCL; ASK-45703-PNW; Exp. Dates Feb 2018 - Nov 2018

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·February 28, 2018

    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions; Product Codes: ASK-45703-SCH; ASK-45703-UAB, ASK-45703-VAH

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018

    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip¿, ARROWg+ard Blue PLUS¿ Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Codes: ASK-45703-LDP1, ASK-45703-PBHS, ASK-45703-PHMC

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018

    AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3) AK-45703-PB1A; AGB+ Pressure Injectable Multi-Lumen CVC Kit (4) CA-42703-P1A; (5) CA-42854-P1A; (6) CA-45703-P1A; AGB+ Pressure Injectable Quad-Lumen CVC Kit (7) CA-45854-P1A; (8) CDA-42703-P1A; AGB+ Quad-Lumen CVC Kit (9) AK-42854-P1A; (10) AK-45854-P1A; AGB+ Two Lumen CVC Kit (11) AK-42802-P1A; (12) AK-45802-P1A; (13) AK-46702-P1A; (14) AK-47702-P1A; ARROWg+ard BLUE PLUS Pressure Injectable Multi-Lumen CVC Kit (15) CDA-45703-P1A; ARROWg+ard BLUE PLUS Pressure Injectable Quad-Lumen CVC Kit (16) CDA-45854-P1A; ARROWg+ard BLUE PLUS Pressure Injectable Two-Lumen CVC Kit (17) CDA-22122-U1A; (18) CDA-42802-P1A; (19) CDA-42854-P1A; (20) CDA-47702-P1A; ARROWg+ard Blue¿ MAC" Two-Lumen CVC Access Kit (21) CDA-21242-1A; ARROWg+ard Blue¿ PSI Kit (22) CDA-29803-1A; ARROWg+ard Blue¿ Two-Lumen CVC Kit (23) AK-22702-P1A; ARROWg+ard Blue¿ You-Bend" Two- Lumen Hemodialysis Catheterization Kit for High Volume Infusions (24) CDA-25122-U1A; Multi-Lumen CVC Kit with Blue FlexTip(R) Catheter and Sharps Safety Features (25) ASK-12703-PRJ; (26) ASK-15703-PRJ; Multi-Lumen Pressure Injectable Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features (27) ASK-45703-PRH; Pressure Injectable ARROWg+ard Blue Plus(R) Multi-Lumen CVC Kit (28) ASK-45703-PRWJ1; Pressure Injectable ARROWg+ard Blue PLUS(R) Quad-Lumen CVC Kit (29) ASK-42854-PRJ; Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central CVC Kit (30) ASK-47702-PPHP; Pressure Injectable ARROWg+ard Blue PLUS(R)Multi-Lumen CVC Kit (31) ASK-45703-PUCD; Pressure Injectable Multi-Lumen CVC Kit (32) ASK-12703-PCA; (33) ASK-15703-PCA; (34) ASK-15703-PHH; (35) ASK-15703-PLV; Pressure Injectable Multi-Lumen CVC kit with Blue Flex Tip¿, ARROWg+ard Blue PLUS¿ Catheter and Sharps Safety Features (36) ASK-42703-PBM; (37) ASK-15703-PRH; (38) ASK-15703-PRWJ; (39) ASK-42703-PRJ; (40) ASK-45703-PRJ; Pressure Injectable Quad-Lumen CVC Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions (41) ASK-42854-PNMM; Pressure Injectable Two Lumen CVC Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features (42) ASK-42802-PBM

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 18, 2018

    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)

    FDA Enforcement
    Class III ·Terminated·GSK Consumer Healthcare·July 20, 2016

    InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthopedic / spinal procedures.

    FDA Enforcement
    Class II ·Terminated·Zavation·June 9, 2021

    Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters; Product Codes: ASK-29803-SJH, ASK-29903-SJH, and ASK-29903-UW1

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018

    Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·September 9, 2015

    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·July 20, 2016

    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·July 20, 2016