BEUDAMED
    23 results · 13ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Terminated × Clear all

    Bausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, Rochester, NY 14609. The product is packed in 1 fl oz (30 mL), 3 fl oz (90 mL), 3.5 fl oz (105 mL) and 4 fl oz (120 ml) bottles.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code MRC·October 30, 2009

    Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).

    FDA Recall
    Terminated ·Alivecor SFO·Product code DXH·January 9, 2015

    AQuify Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact Lenses * 1/3 fl. Oz. (10mL) * Sterile * CIBA Vision Corp. Made In Canada Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA

    FDA Recall
    Terminated ·Ciba Vision Corporation·Product code MRC·November 2, 2005

    Bausch & Lomb, Boston Conditioning Solution, Original Formula, For Rigid Gas Permeable Contact Lenses, 1 fl. oz. (30 ml), Bausch & Lomb Incorporated, Rochester, NY 14609.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code LPN·June 30, 2009

    Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.

    FDA Recall
    Terminated ·MEDLINE IND·Product code KMJ·December 12, 2016

    Bausch & Lomb, Renu Fresh Multi-purpose Solution, 2 fl oz (60 mL), Travel Kit, Manufactured by: Bausch & Lomb Place, Rochester, NY 14609 Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code LYL·December 22, 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

    Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 90 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-104.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code FFL·December 20, 2005

    IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage: The DSL6600 IGFBP-3 immunoradiometric assay (IRMA) kit provides materials for the quantitative measurement of IGFBP-3 in serum. This assay is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CFL·August 9, 2010

    Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 120 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-105.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code FFL·December 20, 2005

    Bard Platinum Class II Flat Wire Stone Basket, Ureteral Stone Dislodger, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code FFL·December 22, 2003

    Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code FFL·December 22, 2003

    The Hospira Plum A+3 I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets.

    FDA Recall
    Terminated ·Hospira Inc·Product code JFL·September 8, 2004

    ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide in human serum or plasma.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JFL·January 29, 2020

    V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket, Without Filiform Tip; a sterile, single use kidney stone retriever device; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA

    FDA Recall
    Terminated ·Cardinal Health 1430 Waukegan Rd Attn V. Mueller Qa McGaw Park IL 60085·Product code FFL·October 27, 2004

    Nichols Advantage Sample hGH Diluent Set (Catalog No. 62-7756)

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code CFL·May 2, 2005

    IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFL·April 15, 2016

    ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code CFL·March 5, 2018

    Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle, shaft and basket. It is intended to use in the endoscopic removal of renal and ureteral stones.

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code FFL·October 7, 2014

    IGFBP-3 ELISA Reagent Kit; Part Number" DSL-10-6600; Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830 This assay is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CFL·March 30, 2011