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    Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which is placed, during arthroplasty, in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the bones and becomes stabilized by the encapsulation process. The implant is available in eleven sizes to meet various anatomical variations and is supplied sterile. Component: N/A

    FDA Recall
    Open, Classified ·Osteotec Limited·Product code KYJ·June 18, 2025

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

    FDA Recall
    Terminated ·Mizuho OSI·Product code JEA·December 17, 2012

    HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

    FDA Recall
    Open, Classified ·Mizuho OSI·Product code LXH·July 29, 2021

    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 Recall
    Terminated ·Mizuho OSI·Product code FWZ·March 28, 2017

    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 Recall
    Terminated ·Mizuho OSI·Product code GDC·December 14, 2015

    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 Recall
    Terminated ·Mizuho OSI·Product code JEA·October 14, 2019

    Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.

    FDA Recall
    Open, Classified ·Mizuho OSI·Product code GDC·February 8, 2021

    VariSoft Infusion Set, Single Use.

    FDA Recall
    Open, Classified ·Unomedical A/S Osted Aholmvej 1·Product code FPA·July 23, 2024

    Neria Soft Infusion Set, Product Code 507302, intravascular administration set

    FDA Recall
    Open, Classified ·Unomedical A/S Osted Aholmvej 1·Product code FPA·March 5, 2024

    UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006

    FDA Recall
    Open, Classified ·UFSK International OSYS Gmbh Kirchhoffstr. 1 Ratisbon Germany·Product code HME·May 31, 2023

    GE Datex-Ohmeda Advance Anesthesia Gas-Machine.

    FDA Recall
    Terminated ·GE Healthcare·Product code BSZ·February 5, 2009

    Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.

    FDA Recall
    Terminated ·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code BSZ·August 13, 2012

    Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable Analgesia Gas Machine.

    FDA Recall
    Terminated ·Accutron Inc·Product code BSZ·April 29, 2012

    CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.

    FDA Recall
    Terminated ·Accutron Inc·Product code BSZ·April 29, 2012

    GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code BSZ·August 28, 2013

    McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.

    FDA Recall
    Terminated ·MCKESSON TECHNOLOGIES INC.·Product code BSZ·March 15, 2013

    GE Datex-Ohmeda ADU Carestation Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients.

    FDA Recall
    Terminated ·GE Healthcare·Product code BSZ·October 30, 2008

    Datex-Ohmeda S/5 Aespire Anesthesia System 7100

    FDA Recall
    Terminated ·Datex-Ohmeda Inc·Product code BSZ·September 27, 2005

    GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor

    FDA Recall
    Terminated ·Ge Healthcare, Llc·Product code BSZ·March 12, 2010

    FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code BSZ·April 2, 2015