FMK
Safety Lancet
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 109
Adverse events under product code FMK
product code FMK- Injury
- 133
- Malfunction
- 1,278
- Other
- 1
- Total
- 1,412
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FMK
1–100 of 109- K260191 — Safety lancet (XXXVII)
- K253605 — Safety Heel Lancet
- K252490 — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
- K251694 — safety lancet
- K244036 — Heel Incision Safety Lancet (SteriHeel 2)
- K242680 — LetsGetChecked Impress
- K243533 — Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus
- K242664 — gentleheel® Adult Incision Device
- K242627 — Safety Lancet
- K242316 — Safety Lancet
- K241848 — MedtFine Safety Lancet
- K241750 — Medifun Safety Lancet ( MSL1 series)
- K241627 — Safety Lancet (XXXV)
- K240806 — Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)
- K234081 — RedDrop ONE (One)
- K223826 — NanoDrop Lancet
- K233796 — Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)
- K232488 — Accu-Chek Safe-T-Pro Plus Lancing Device
- K232509 — Accu-Chek Safe-T-Pro Uno Lancing Device
- K231124 — Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)
- K223201 — TAP Lancet
- K223352 — Tenderfoot
- K223900 — babyLance Safety Heelstick (BLM, BLN, BLP)
- K223370 — NeatNick Heel Safety Lancet
- K223208 — Safety Lancet
- K222801 — Safety Lancet
- K223313 — Disposable Safety Lancets
- K223243 — BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets
- K222408 — Disposable Safety Lancet
- K222055 — Disposable Sterile Lancet
- K222168 — Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler
- K222084 — OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie
- K221521 — Disposable Safety Lancet
- K222303 — Unistik® Pro
- K221783 — SafetiCET Safety Lancet
- K221778 — Disposable Safety Lancets
- K222376 — Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)
- K222090 — Safety Lancet
- K222224 — SurgiLance® Safety Lancet
- K221839 — Lancet
- K222111 — Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G
- K221604 — SafetiHeel, MediHeel, Novaplus
- K221126 — Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets
- K221131 — Tasso+
- K220643 — DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets
- K221368 — Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
- K221371 — Promisemed Heel Blood Lancet
- K220370 — Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
- K220849 — Accu-Chek Safe-T-Pro Plus Lancing Device
- K220917 — gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler
- K220372 — Heel Stick Safety Lancet (HHZ-II, HHZ-III)
- K220364 — Accu-Chek Safe-T-Pro Uno Lancing Device
- K210745 — Heel Incision Safety Lancet
- K193009 — Promisemed Heel Blood Lancet
- K192666 — Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
- K172712 — gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler
- K153670 — Genteel Lancing Device
- K130132 — BABYLANCE HEEL INCISION DEVICE
- K113513 — PLANCET
- K113332 — ON CALL CHOSEN LANCING DEVICE
- K101145 — SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250
- K101417 — BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200
- K041665 — L1-PRO SYSTEM
- K024170 — L1 SYSTEM
- K001162 — GOLDFINGER DEVICE
- K944948 — FREE-LANCE
- K942548 — JENNINGS JAVELIN
- K942620 — FEATHER-TOUCH SINGLE-STICK DEVICE
- K931258 — SOFTTOUCH II LANCET DEVICE
- K933365 — BABISTICK
- K931828 — CARELET SAFETY LANCET
- K931481 — MINI-LANCET
- K932785 — MONOJECT(R) MONOLETTOR SAFETY LANCET
- K931827 — CLEANLET, CLEANLET XL & KIDS
- K932725 — B-D ULTRA FINE(R) LANCET
- K923302 — TENDERLETT FINGER
- K920562 — UNISTIK
- K911997 — TENDERFOOT(R), MODIFICATION
- K902430 — GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD
- K902416 — SURELITE AND SURELITE XL BLOOD LANCET
- K894427 — DISPOSABLE IV INDUCTION COVER
- K894474 — THE AUTOLET LITE
- K885342 — GENNY DENNY IV SHIELD
- K883968 — TENDERFOOT
- K883957 — ARTERIAL ANCHOR BANDAGE
- K883420 — LANCET, BLOOD
- K880869 — MEDI-LET
- K850100 — BLOOD LANCET
- K870017 — AMG + MED LANCET
- K865016 — BLOOD LANCET
- K863621 — PALS
- K861265 — DIALET LANCING DEVICE
- K861243 — NEONATAL UNILET
- K861151 — SUEL BLOOD LANCET
- K855203 — GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD
- K854760 — CHURCHHILL LANCET
- K850150 — ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED
- K841677 — STERILE BLOOD LANCETS
- K833816 — HEMASTICK 1-1.5 & 2-DISPOS. BLOOD
- K833812 — SUPERJET DISPOSABLE BLOOD LANCET
Data sourced from openFDA. This site is unofficial and independent of the FDA.