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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 19, 2022 | K220370 | Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) Tianjin Huahong Technology Co., Ltd., CN | FMK |
| May 18, 2022 | K220917 | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler Gri-Alleset, Inc. | FMK |
| May 17, 2022 | K220372 | Heel Stick Safety Lancet (HHZ-II, HHZ-III) Tianjin Huahong Technology Co., Ltd., CN | FMK |
| Apr 5, 2022 | K220364 | Accu-Chek Safe-T-Pro Uno Lancing Device Roche Diabetes Care, Inc. | FMK |
| Aug 26, 2021 | K210745 | Heel Incision Safety Lancet SteriLance Medical (Suzhou), Inc., CN | FMK |
| Dec 3, 2019 | K193009 | Promisemed Heel Blood Lancet Promisemed Hangzhou Meditech Co., Ltd., CN | FMK |
| Dec 2, 2019 | K192666 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet Promisemed Hangzhou Meditech Co., Ltd., CN | FMK |
| Nov 6, 2017 | K172712 | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler Gri Medical & Electronic Technology Co., Ltd., CN | FMK |
| May 12, 2016 | K153670 | Genteel Lancing Device Genteel, LLC | FMK |
| Feb 11, 2013 | K130132 | BABYLANCE HEEL INCISION DEVICE Medipurpose Pte. , Ltd. | FMK |
| Jul 13, 2012 | K113513 | PLANCET Micropoint Technologies Pte, Ltd., SG | FMK |
| Apr 18, 2012 | K113332 | ON CALL CHOSEN LANCING DEVICE ACON Laboratories, Inc. | FMK |
| Oct 21, 2010 | K101145 | SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 Medipurpose Pte. , Ltd. | FMK |
| Oct 19, 2010 | K101417 | BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 Medipurpose Pte. , Ltd. | FMK |
| Jul 23, 2004 | K041665 | L1-PRO SYSTEM Pelikan Technologies, Inc. | FMK |
| Apr 14, 2003 | K024170 | L1 SYSTEM Pelikan Technologies, Inc. | FMK |
| Aug 9, 2000 | K001162 | GOLDFINGER DEVICE Mali-Tech , Ltd., IL | FMK |
| Nov 17, 1994 | K944948 | FREE-LANCE F.F.F. Enterprises, Inc. | FMK |
| Nov 3, 1994 | K942548 | JENNINGS JAVELIN Jfi Endineering, Inc. | FMK |
| Jun 22, 1994 | K942620 | FEATHER-TOUCH SINGLE-STICK DEVICE Ulster Scientific, Inc. | FMK |
| Feb 10, 1994 | K931258 | SOFTTOUCH II LANCET DEVICE Boehringer Mannheim Corp. | FMK |
| Oct 19, 1993 | K933365 | BABISTICK Graphic Controls Corp. | FMK |
| Oct 15, 1993 | K931828 | CARELET SAFETY LANCET Gainor Medical Europe, Ltd. | FMK |
| Oct 1, 1993 | K931481 | MINI-LANCET Pacific Rim Products, Inc., AU | FMK |
| Sep 29, 1993 | K932785 | MONOJECT(R) MONOLETTOR SAFETY LANCET Sherwood Medical Co. | FMK |
| Sep 13, 1993 | K931827 | CLEANLET, CLEANLET XL & KIDS Gainor Medical Europe, Ltd. | FMK |
| Jul 23, 1993 | K932725 | B-D ULTRA FINE(R) LANCET Bd Becton Dickinson Vacutainer Systems Preanalytic | FMK |
| Jan 22, 1993 | K923302 | TENDERLETT FINGER International Technidyne Corp. | FMK |
| Mar 27, 1992 | K920562 | UNISTIK Ulster Scientific, Inc. | FMK |
| Jul 17, 1991 | K911997 | TENDERFOOT(R), MODIFICATION International Technidyne Corp. | FMK |
| Aug 2, 1990 | K902430 | GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD Heraeus Kulzer, Inc. | FMK |
| Aug 1, 1990 | K902416 | SURELITE AND SURELITE XL BLOOD LANCET Gainor Medical Europe, Ltd. | FMK |
| Sep 11, 1989 | K894427 | DISPOSABLE IV INDUCTION COVER Central Plastic, Inc. | FMK |
| Aug 18, 1989 | K894474 | THE AUTOLET LITE Ulster Scientific, Inc. | FMK |
| Mar 30, 1989 | K885342 | GENNY DENNY IV SHIELD Mercury Enterprises, Inc. | FMK |
| Dec 1, 1988 | K883968 | TENDERFOOT International Technidyne Corp. | FMK |
| Oct 18, 1988 | K883957 | ARTERIAL ANCHOR BANDAGE Guidelines, Inc. | FMK |
| Aug 26, 1988 | K883420 | LANCET, BLOOD Primrose Medical, Inc. | FMK |
| Mar 21, 1988 | K880869 | MEDI-LET Medicore, Inc. | FMK |
| Jan 29, 1987 | K850100 | BLOOD LANCET Gainor Medical | FMK |
| Jan 21, 1987 | K870017 | AMG + MED LANCET Can-Am Surgical Corp. | FMK |
| Jan 12, 1987 | K865016 | BLOOD LANCET Falcon Medical Industries, Inc. | FMK |
| Oct 6, 1986 | K863621 | PALS West Lake Marketing | FMK |
| Apr 30, 1986 | K861265 | DIALET LANCING DEVICE Home Diagnostics, Inc. | FMK |
| Apr 29, 1986 | K861243 | NEONATAL UNILET Ulster Scientific, Inc. | FMK |
| Apr 15, 1986 | K861151 | SUEL BLOOD LANCET Exel Intl. | FMK |
| Feb 11, 1986 | K855203 | GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD Miles Laboratories, Inc. | FMK |
| Jan 3, 1986 | K854760 | CHURCHHILL LANCET Churchill Corp. | FMK |
| Feb 21, 1985 | K850150 | ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED Gainor Medical | FMK |
| Jun 11, 1984 | K841677 | STERILE BLOOD LANCETS Abco Dealers, Inc. | FMK |
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