BEUDAMED
    20 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 Status: Terminated ×

    Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.

    FDA Enforcement
    Class II ·Terminated·Catheter Research, Inc·April 29, 2015

    Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples

    FDA Enforcement
    Class II ·Terminated·Aspen Surgical Products, Inc.·August 28, 2013

    Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·December 18, 2013

    Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Center Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN Product No. H7496013198101 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire.

    FDA Enforcement
    Class II ·Terminated·AngioDynamics Inc.·April 13, 2016

    PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. Starter Kit US), Manufactured by Bausch + Lomb, Rochester, NY 14609. PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses.

    FDA Enforcement
    Class II ·Terminated·Bausch & Lomb Inc Irb·November 30, 2016

    SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·June 7, 2017

    BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative determination of the thrombin time in citrated human plasma.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics·March 7, 2018

    IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·February 8, 2017

    ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491244 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is being marketed on the XPT following FDAs Reagent Replacement Policy. Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·November 23, 2016

    ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491379 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is being marketed on the XPT following FDAs Reagent Replacement Policy. Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·November 23, 2016

    Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available. The number of unique users for each affected version from the date of initial distribution through 03/23/2017 is noted in 7a. However, some users will have used all three affected versions as they upgraded from version to version when the versions became available and many others will have tried the app and discontinued use. In the last 30 days, 02/22/2017 03/23/2017, there have been 16,781 unique users in the US with 264 of those seeking bolus advice and 19,268 unique users in the rest of world (excluding Canada) with 415 of those users seeking bolus advice.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code NDC·March 14, 2017

    Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available. The number of unique users for each affected version from the date of initial distribution through 03/23/2017 is noted in 7a. However, some users will have used all three affected versions as they upgraded from version to version when the versions became available and many others will have tried the app and discontinued use. In the last 30 days, 02/22/2017 03/23/2017, there have been 16,781 unique users in the US with 264 of those seeking bolus advice and 19,268 unique users in the rest of world (excluding Canada) with 415 of those users seeking bolus advice.

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·May 10, 2017

    LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360¿ in either direction. The rotating knob is located to allow for a one-handed technique.

    FDA Enforcement
    Class II ·Terminated·Ethicon Endo-Surgery Inc·July 31, 2013

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012