BEUDAMED
    10,000 results · 51ms · 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 Regulation: Us FDA ×

    SUPERFIT

    FDA UDI
    APPLIED DENTAL, INC.·00814639024975·SUPERFIT Disposable Procedural Face masks, Ear ...

    LANCET - FMK

    FDA Adverse Event
    Malfunction ·HTL STREFA S.A.·Product code FMK·July 27, 2012

    CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD MICROTAINER CONTACT-ACTIVATED LANCET

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMK·April 9, 2020

    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

    FDA classification
    FDA Class 2 ·Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

    Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm. Manual surgical instrument for general use.

    FDA Recall
    Terminated ·International Technidyne Corp·Product code FMK·January 23, 2006

    Virotek SAFEL*E*T 1.0 mm Safety Lancets, 1.0 mm depth, stock code 5000052, packaged in single unit blister packs, 150 or 200 per box, 6 boxes per carton; Virotek, L.L.C., 900 Asbury Dr., Buffalo Grove, IL 60089

    FDA Recall
    Terminated ·Efoora, Inc. dba Virotek, L.L.C.·Product code FMK·May 5, 2005

    ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628

    FDA Recall
    Open, Classified ·Cardinal Health Inc.·Product code FMK·March 16, 2021

    Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Models 3144844001 (10 lancets) and 3583031002 (17 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code FMK·May 13, 2009

    Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1 Lancing Device, 1 Clear Cap and 5 Premier Value Ultra Thin Lancets, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL 33431. Lancing Device intended to be used by diabetes patients that require a drop of capillary blood for testing.

    FDA Recall
    Terminated ·Facet Technologies·Product code FMK·July 18, 2008

    Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMK·September 26, 2007

    ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code FMK·August 19, 2013

    BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lakes, NJ 07417 USA Made in USA. Used to perform heel sticks for the purpose of collecting skin puncture blood.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMK·July 10, 2013

    NeatNick Sweeping Action Heel Lancet - Preemie- Item Number: 1030083 (box of 100) and Item Number: 1030084, case of 1,000 (10 boxes of 100)

    FDA Recall
    Terminated ·Hawaii Medical LLC·Product code FMK·May 11, 2007

    Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet)

    FDA Recall
    Terminated ·Sarstedt Inc·Product code FMK·August 27, 2008

    Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. 26G - Single Use Only, Made In Korea Distributed by Hummingbird Medical, Savannah, GA 100 count Boxes; 40 boxes per case Blood collection by penetrating skin with needle.

    FDA Recall
    Terminated ·KooJoo Trading Company 116-7 Songma-li, Daegoj-myun Gimpo City, Gyeongki-Do Korea, Republic Of (South)·Product code FMK·July 3, 2013

    NeatNick Sweeping Action Heel Lancet -Full-Term- Item Number: 1030085 (box of 100) and Item Number: 1030086, case of 1,000 (10 boxes of 100)

    FDA Recall
    Terminated ·Hawaii Medical LLC·Product code FMK·May 11, 2007

    ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610

    FDA Recall
    Open, Classified ·Cardinal Health Inc.·Product code FMK·March 16, 2021

    FREESTYLE LANCETS 28G 100CT Item Number:2975670

    FDA Recall
    Open, Classified ·Cardinal Health Inc.·Product code FMK·March 16, 2021

    Virotek SAFEL*E*T 2.0 mm Safety Lancets, 2.0 mm depth, stock code 5000052, packaged in single unit blister packs, 200 per box, 6 boxes per carton, stock code 5000101, packaged in single unit blue cap packaging, 100 per box, and stock code 5000115, packaged in single unit blue cap packaging, 200 per box; Virotek, L.L.C., 900 Asbury Dr., Buffalo Grove, IL 60089

    FDA Recall
    Terminated ·Efoora, Inc. dba Virotek, L.L.C.·Product code FMK·May 5, 2005