BEUDAMED
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    Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes a supply voltage of 230 V. Article Number 10446782 utilizes a supply voltage of 110 V. Intended to be used for improving the visibility of objects through magnification and illumination.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems, Inc.·June 18, 2014

    Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes a supply voltage of 230 V. Article Number 10446782 utilizes a supply voltage of 110 V. Intended to be used for improving the visibility of objects through magnification and illumination.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code OUE·September 11, 2013

    Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·March 26, 2014

    Natural-Knee Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·February 25, 2014

    Multi Absorbers, reference number 8003138, in S/5 Aespire Start-up Kits (each containing 2 Multi Absorbers)

    FDA Recall
    Terminated ·Datex-Ohmeda·Product code BSF·February 12, 2003

    The IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE rebreathing systems --- Manufactured in the United Kingdom for: Intersurgical Incorporated --- 417 Electronics Parkway, Liverpool, NY 13088. Intended use: GE Healthcare anesthetic machines: S5 Aespire, S5 Avance, Aisys. The Intersurgical IS Can is for use with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane.

    FDA Recall
    Terminated ·Intersurgical Inc·Product code BSF·February 9, 2011

    Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code BSF·September 19, 2013

    POWERSAIL Coronary Dilatation Catheter: 3.25x18mm (US) Part #1005524-18

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code MAF·June 17, 2009

    POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code MAF·June 17, 2009

    Voyager RX Coronary Dilatation Catheter

    FDA Recall
    Terminated ·Guidant Corporation Advanced CardiovascularSystem·Product code MAF·January 27, 2005

    MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13

    FDA Recall
    Terminated ·Guidant Corporation ACS·Product code MAF·May 7, 2003

    CP STENT (Cheatham Platinum), a prescription device, composed of 90% platinum/10% iridium wire arranged in laser welded rows with a ''zig'' pattern. The number of zigs can be varied and will impact the strength of the stent as well as the eventual diameter and percent stent shortening. CP stents are sold either sterile or non-sterile, and sold in different lengths.

    FDA Recall
    Terminated ·Numed Inc·Product code MAF·June 26, 2003

    BiodivYsio SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter; Catalog #: B3225-10, Lot #: 010586G; Catalog #: B3225-10, Lot #: 030176G; Catalog #: B3225-15, Lot #: 010626G; Catalog #: B3225-18, Lot #: 020246G.

    FDA Recall
    Terminated ·Abbott Vascular Devices·Product code MAF·July 21, 2003

    Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code MAF·October 24, 2019

    Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250

    FDA Recall
    Terminated ·Product code MAF·March 20, 2003

    POWERSAIL Coronary Dilatation Catheter: 2.75x18mm (US) Part #1005522-18

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code MAF·June 17, 2009

    Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500401

    FDA Recall
    Terminated ·Product code MAF·March 17, 2003

    Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models: NT186901(D); NT187901(D); NT186902(D); NT187902(D); NT356901(D); NT357901(D);NT356902; NT357902(D)

    FDA Recall
    Terminated ·Edwards Lifesciences Llc One Edwards Way·Product code MAF·April 28, 2005

    Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code MAF·July 16, 2007

    GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory for these anesthesia systems.

    FDA Recall
    Terminated ·Datex Ohmeda, Inc·Product code BSF·July 24, 2007