ClearanceBrief
Panels › General, Plastic Surgery › Product code FMK · Class 2

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

Regulation 878.4850

5510(k)s in 12 months (111 all time)
0recalls in 12 months (17 all time)
1recalls that name a 510(k)
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Top companies in FMK

DateFirm and productCodeLinked 510(k)
Mar 16, 2021Cardinal Health Inc.
ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
Open, Classified
FMKNone listed
Mar 16, 2021Cardinal Health Inc.
ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
Open, Classified
FMKNone listed
Mar 16, 2021Cardinal Health Inc.
ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
Open, Classified
FMKNone listed
Mar 16, 2021Cardinal Health Inc.
FREESTYLE LANCETS 28G 100CT Item Number:2975670
Open, Classified
FMKNone listed
Sep 11, 2013Becton Dickinson & Company
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 fo
Terminated
FMKNone listed
Aug 28, 2013Roche Diagnostics Operations, Inc.
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Terminated
FMKNone listed
Jul 13, 2013KooJoo Trading Company
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 Distribute
Terminated
FMKNone listed
Aug 11, 2009Roche Diagnostics Corp.
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
Terminated
FMKNone listed
Oct 27, 2008Facet Technologies
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
Terminated
FMKNone listed
Oct 14, 2008Sarstedt Inc
Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet)
Terminated
FMKNone listed
Oct 18, 2007Becton Dickinson & Company
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
Terminated
FMKNone listed
Aug 16, 2007Lifescan Inc
One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200
Terminated
FMKNone listed
Jun 9, 2007Hawaii Medical LLC
NeatNick Sweeping Action Heel Lancet - Preemie- Item Number: 1030083 (box of 100) and Item Number: 1030084, case of 1,000 (10 boxes of 100)
Terminated
FMKNone listed
Jun 9, 2007Hawaii Medical LLC
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)
Terminated
FMKNone listed
Mar 23, 2006International Technidyne Corp
Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm. Manual surgical instrument for general use.
Terminated
FMKK923302
Jun 17, 2005Efoora, Inc. dba Virotek, L.L.C.
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
Terminated
FMKNone listed
Jun 17, 2005Efoora, Inc. dba Virotek, L.L.C.
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
Terminated
FMKNone listed

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