BEUDAMED
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    ESSENTIO MRI DR

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWP·April 15, 2026

    Arthrocare 3.0mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5030, Axya Medical, Inc., Beverly, MA 01915

    FDA Recall
    Terminated ·Axya Medical·Product code MBI·September 27, 2007

    Arthrocare 5.5mm ParaSorb, pre-loaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5055 , Axya Medical, Inc., Beverly, MA 01915

    FDA Recall
    Terminated ·Axya Medical·Product code MBI·September 27, 2007

    Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5065, Axya Medical, Inc., Beverly, MA 01915

    FDA Recall
    Terminated ·Axya Medical·Product code MBI·September 27, 2007

    Arthrocare 5.5mm ParaSorb, pre-loaded with 2 MagnumWire sutures (1 white/1 co-braid) with needle Part Number: 22-5055N, Axya Medical, Inc., Beverly, MA 01915

    FDA Recall
    Terminated ·Axya Medical·Product code MBI·September 27, 2007

    Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid) with needle Part Number:22-5065N, Axya Medical, Inc., Beverly, MA 01915

    FDA Recall
    Terminated ·Axya Medical·Product code MBI·September 27, 2007

    Imager" II Urology Torque Catheter, Sterilized with ethylene oxide gas, Manufactured for Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, USA, Made in Ireland, Unit 7,8 & 9 Annacotty Business Park, Annocotty, Co. Limerick, Ireland: Product Description and Material/UPN/Catalog Number Imager" II Catheters C2, 5Fr, 65cm M0064003010 (inner pouch) M0064003011 (outer box); Imager" II Catheters Straight, 5Fr, 65cm M0064003020 (inner pouch) M0064003021 (outer box) and Imager" II Catheters Bern, 5Fr, 65cm M0064003030 (inner pouch) M0064003031 (outer box) The Imager II Urology Torque Catheter is single lumen, torqueable catheter that is offered with one of a variety of tip configurations, each uniquely designed to facilitate access to the urinary tract. This device is made of a bio-compatible polymer reinforced with a stainless steal braided wire with one hole at the distal tip and a luer lock hub is attached to the proximal end. The catheter may be used with a guidewire up to .038 in. diameter.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOD·October 22, 2009

    Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers: E03971AA;E03981AA;E30421AA;E30431AA;E30591CA;E30591HD;E30591HL;E30591EB;E30511P;E30591AB;E30591B;E30511Q;E30591C;E30591A;E30591RR;E30591CB;E30591E;E33591PA;E33591PC. Product Usage: Personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 11, 2014