BEUDAMED
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    12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H, CS-12123-E, MA-12123, and MC-12123. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins.

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·May 8, 2009

    Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J

    FDA Recall
    Terminated ·Arrow International Inc·Product code DYG·November 15, 2019

    Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130

    FDA Recall
    Terminated ·Arrow International Inc·Product code DYG·November 15, 2019

    O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4

    FDA Recall
    Terminated ·Orchestrate Orthodontic Technologies, Inc.·Product code PNN·November 11, 2021

    Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges, and posts.

    FDA Recall
    Terminated ·Kerr Corporation·Product code EMA·December 2, 2010

    Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and Intended Use: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates. Product Usage: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates.

    FDA Recall
    Terminated ·Kerr Corporation·Product code EMA·March 3, 2011

    Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Opaque; The product is intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the pulp.

    FDA Recall
    Terminated ·Bisco Inc·Product code EMA·April 28, 2008

    Maxcem Elite(TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g, REF/Part # 33872, CLEAR --- Refill Kit Contents: 2 Syringes (5 g ea), 10 Automix tips (regular) 4:1, 10 Automix tips (wide) 4:1, 10 Intra-oral tips Dental resin cement. Self-etch, self-adhesive resin cement. High bond strength without adhesive needed. Easy to clean up and can be used with all anterior and posterior ceramics, PFMs, and CAD/CAM materials. Color stable and aesthetic. Works with all substrates from opaque to translucent.

    FDA Recall
    Terminated ·Henry Schein, Inc.·Product code EMA·November 10, 2011

    Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restorations including veneers, inlays, onlays, bridges, posts, and the cementation of crown restorations to implant abutments.

    FDA Recall
    Terminated ·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·Product code EMA·February 25, 2020

    Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Translucent; The product is intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the pulp.

    FDA Recall
    Terminated ·Bisco Inc·Product code EMA·April 28, 2008

    Brand Name: TempSpan CMT Temporary Cement, a temporary cement. Part Number: N69CA. The intended use of this device is to affix a temporary dental devices such as crowns or bridges to a tooth.

    FDA Recall
    Terminated ·Kerr Corporation·Product code EMA·March 3, 2011

    Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It). The intended use of this device is to affix dental devices such as crowns or bridges onto the tooth. Cement-It and Natural Elegance (private label of Cement-It) are indicated as a luting cement bonding system for porcelain crowns, inlays, and onlays and other dental restorations, including ceramics, metal alloys and composite restoratives.

    FDA Recall
    Terminated ·Kerr/pentron Dba Kerr Corporation And Pentron Clinical·Product code EMA·March 17, 2011

    Breeze Self-Adhesive Resin Cement, Part Number: N97A, Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.

    FDA Recall
    Terminated ·Kerr/pentron Dba Kerr Corporation And Pentron Clinical·Product code EMA·July 8, 2011

    TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637

    FDA Recall
    Terminated ·Kerr Corp·Product code EMA·August 14, 2006

    Kerr TempBond Clear, Part # 33351, 1717 West Collins Avenue, Orange, CA 92867. Intended for use in a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restoration such as crowns, bridges, inlays and onlays.

    FDA Recall
    Terminated ·Kerr Corp·Product code EMA·September 9, 2009

    Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014

    SOMATOM Force, System x-ray, tomography, computed

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 14, 2016

    Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

    FDA Enforcement
    Class II ·Terminated·Cytocell Ltd.·August 25, 2021

    3M Micropore Paper Tape, Cat. No. 1530-154, 1 in x 54 in., 800 rolls / case.

    FDA Recall
    Terminated ·Product code KGX·January 29, 2010

    3M Micropore Paper Tape, Cat. No. 1530-15Y, 1 in x 5YDS., 441 rolls / case.

    FDA Recall
    Terminated ·Product code KGX·January 29, 2010