BEUDAMED
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    Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

    FDA Recall
    Terminated ·Neuro Kinetics, Inc.·Product code GWN·July 21, 2015

    Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468.

    FDA Recall
    Terminated ·Cyberkinetics Neurotechnology Systems, Inc.·Product code GZL·February 4, 2009

    BioCare Medical Vina Green Chromogen Kit; 25 mL, 100ml IVD. Kits include: Vina Green Chromogen 1. 0 mL; Vina Green Buffer, 25 mL and Vina Green Dropper Bottle. BioCare Medical, Concord, CA 94520. Vina Green is intended for both IHC and ISH applications including HPV, CMV, EBV, Kappa, TTF-1, Ki-67 and other targets/antigens such as blood and lymphatic vessels and basal and myoepithelial cells.

    FDA Recall
    Terminated ·Biocare Medical Llc·Product code NJT·March 13, 2012

    Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Propper Manufacturing Co., Inc., Long Island City, N.Y. 11101

    FDA Recall
    Terminated ·Propper Mfg Co Inc·Product code JOJ·February 7, 2008

    VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 14626.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LEG·April 18, 2005

    Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport.

    FDA Recall
    Terminated ·Ki Mobility Llc·Product code INM·November 19, 2021

    KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak DirectView CR 500 systems. Responsible firm on label: Made in U.S.A. by Eastman Kodak Company, Rochester, N.Y. 14650. Screens are sold in the following sizes and Cat. Nos: (1) Cat. #812-7334 - 15 x 30 cm; (2) Cat #825-9269 - 18 x 24 cm; (3) Cat #167-8663 - 24 x 30 cm; (4) Cat #810-7823 - 35 x 35 cm; (5) Cat #160-5906 - 35 x 43 cm

    FDA Recall
    Terminated ·Eastman Kodak Co·Product code IXJ·April 8, 2005

    propper brand cal-mark(R), Micro-Hematocrit Calibrated Capillary Tubes, CALIBRATED-HEPARINIZED, reorder no. 043021, 6 Vials, 100 Tubes per Vial, Length 75 mm., 0.55 mm. I.D., 1.40-1.75mm. O.D. Calibrated 60mm from end for use in direct reading centrifuges. Fill to the 60mm mark with blood and seal opposite end by flame or with sealing compound. If centrifuged on a direct reading centrifuge, read percent hematocrit directly from scale on the centrifuge. Otherwise, read in normal manner as a percent ratio of packed cells with 60mm of sample as 100%. Firm on label: propper manufacturing co., inc., long island city, n.y. 11101.

    FDA Recall
    Terminated ·Propper Mfg Co Inc·Product code G-IO·August 9, 2002

    Revanesse Versa, PN40081

    FDA Recall
    Terminated ·Prollenium Medical Technologies Inc. 138 Industrial Pky N Aurora Canada·Product code LMH·November 15, 2018

    Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Ambler Surgical brand name.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HKY·September 8, 2014

    ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009

    FDA Recall
    Open, Classified ·Stryker Medical Division of Stryker Corporation·Product code IKY·May 12, 2021

    Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a point-of-care solution with the versatility of patient handling and transferring, which encourages ease of use and compliance. The design provides airflow to aid in patient comfort and pressure injury prevention.

    FDA Recall
    Terminated ·EHOB, Inc.·Product code IKY·January 19, 2020

    Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code HKI·December 9, 2016

    RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.

    FDA Recall
    Terminated ·Clarity Medical Systems Inc·Product code HKI·January 24, 2014

    Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code HKI·December 9, 2016

    Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Millennium Surgical, Symmetry Surgical, Accutome, Boss Instruments, and Medline Industries brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HKY·September 8, 2014

    Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #2710000027

    FDA Recall
    Open, Classified ·Stryker Medical Division of Stryker Corporation·Product code IKY·May 12, 2021

    BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131

    FDA Recall
    Terminated ·BD Biosciences·Product code GKI·October 2, 2007

    Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.

    FDA Recall
    Terminated ·Clarity Medical Systems Inc·Product code HKI·March 7, 2014

    NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.

    FDA Recall
    Terminated ·Nidek Inc·Product code HKI·August 1, 2013