BEUDAMED
    241 results · 12ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Terminated × Clear all

    Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090

    FDA Recall
    Terminated ·Signal Medical Corporation·Product code GFJ·February 20, 2017

    smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code GFJ·November 11, 2019

    PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.

    FDA Recall
    Terminated ·Dako North America Inc.·Product code PLS·February 2, 2018

    GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010

    FDA Recall
    Terminated ·GE Healthcare Integrated IT Solutions·Product code LLZ·December 28, 2007

    ACCESS TRAY/Product SKU's (Codes) ASK-03000-CHUQ, ASK-03000-CHUQ1, ASK-04001-GFH, ASK-04001-SUH and ASK-04001-UHC. Access tray for epidural anesthesia kit

    FDA Recall
    Terminated ·Arrow International Inc·Product code CAZ·October 29, 2010

    Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.

    FDA Recall
    Terminated ·Ivoclar A. G. Fl-9494 Schaan Liechtenstein·Product code EBC·October 7, 2015

    Drop Arm Versamode"

    FDA Recall
    Terminated ·Gf Health Products·Product code ILS·March 24, 2021

    John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube.

    FDA Recall
    Terminated ·Gf Health Products, Inc.·Product code BTO·September 14, 2009

    Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912

    FDA Recall
    Terminated ·GF Health Products, Inc·Product code FNL·September 30, 2016

    Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.).

    FDA Recall
    Terminated ·GF Health Products, Inc./d.b.a.Basic American Metal Products·Product code FNL·July 21, 2014

    LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Plastic Panels, Item 690-7604-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Walnut Panels, Item 690-7004-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. Therapeutic bed intended for home use.

    FDA Recall
    Terminated ·GF Health Products, Inc./d.b.a.Basic American Metal Products·Product code LLI·April 17, 2012

    FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #KNB21.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code GCJ·November 25, 2003

    Extron Electronics OEM, CAB, DVI-Male to DVI-Female Cable Assembly (14 inch.); Part #: 43-111-01 (Stryker Part #: 0100-224-131); Distributed by Stryker Communications, Flower Mound, TX 75028. (These cables are commonly used with the Switchpoint Infinity II)

    FDA Recall
    Terminated ·Stryker Communications·Product code GCJ·October 3, 2007

    Weck Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.

    FDA Recall
    Terminated ·Teleflex Medical·Product code GCJ·March 11, 2014

    Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Recall
    Terminated ·Davol, Inc., Subs. C. R. Bard, Inc.·Product code GCJ·April 24, 2014

    Applied Medical's LAP CHOLE KIT 7 GK; Model Number: GK107 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·September 10, 2010

    Applied Medical's LAP CHOLE ; Model Number: K2155 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·September 10, 2010

    Applied Medical's LAP CHOLE KIT ; Model Number: K0492 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·September 10, 2010

    Endopath Probe Plus II, Curved Dissector Electrode, 5mm shaft, 34 cm length, hollow tip electrode, Code EPS04.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code GCJ·April 20, 2006

    Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code GCJ·June 25, 2008