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)
Top companies in FMK
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2021 | Cardinal Health Inc. ONETOUCH DELICA LANCETS 33G 100 COUNT
Item Number: 5541628 Open, Classified |
FMK | None listed |
| Mar 16, 2021 | Cardinal Health Inc. ONETOUCH DELICA LANCETS 30G 100 COUNT
Item Number: 5541610 Open, Classified |
FMK | None listed |
| Mar 16, 2021 | Cardinal Health Inc. ONETOUCH ULTRASOFT LANCETS 100 COUNT
Item Number: 3007788 Open, Classified |
FMK | None listed |
| Mar 16, 2021 | Cardinal Health Inc. FREESTYLE LANCETS 28G 100CT
Item Number:2975670 Open, Classified |
FMK | None listed |
| Sep 11, 2013 | Becton 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 |
FMK | None listed |
| Aug 28, 2013 | Roche Diagnostics Operations, Inc. ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system. Terminated |
FMK | None listed |
| Jul 13, 2013 | KooJoo 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 |
FMK | None listed |
| Aug 11, 2009 | Roche 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 |
FMK | None listed |
| Oct 27, 2008 | Facet 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 |
FMK | None listed |
| Oct 14, 2008 | Sarstedt Inc Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet) Terminated |
FMK | None listed |
| Oct 18, 2007 | Becton 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 |
FMK | None listed |
| Aug 16, 2007 | Lifescan Inc One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200 Terminated |
FMK | None listed |
| Jun 9, 2007 | Hawaii 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 |
FMK | None listed |
| Jun 9, 2007 | Hawaii 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 |
FMK | None listed |
| Mar 23, 2006 | International 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 |
FMK | K923302 |
| Jun 17, 2005 | Efoora, 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 |
FMK | None listed |
| Jun 17, 2005 | Efoora, 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 |
FMK | None listed |
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