FDA 510(k) clearances — page 421
clearances on record, most recent first.
Clearances — page 421
42,001–42,100 of 175,770- K122853 — NOVEL FIT AND FILL STEM
- K122865 — VIVIX-S WIRELESS
- K123033 — ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B
- K123134 — EASYSPINE SYSTEM
- K123362 — MILAGRO ADVANCE INTERFERENCE SCREW
- K123420 — SYNGO, BREAST CARE
- K123519 — INVIVO DENTAL
- K123538 — EPIEN ROOT CANAL CLEANSER
- K123545 — INCORIS TZI
- K123578 — ANTERIOR CERVICAL PLATE SYSTEM
- K123610 — E-CUBE 15
- K123757 — POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR
- K123995 — MICRODOSE SI
- K112880 — CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE
- K113353 — GEMINI STERILZATION WRAP
- K113530 — ULTRASONIC SCALER
- K122396 — POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K122696 — POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
- K123111 — V8 TRANSLUMINAL BAV CATHETER
- K123196 — PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH
- K123258 — THE ADVANCE CATHETER FOR HSG AND SIS
- K123397 — MULTILINK AUTOMIX
- K123691 — MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
- K123764 — DURETTE OCULAR IMPLANT
- K123775 — LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK
- K130013 — X4 SYSTEM
- K113816 — GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV
- K122300 — T3 DENTAL IMPLANT
- K122752 — FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD
- K122928 — DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA
- K123279 — MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN
- K123369 — ILUMIEN OPTIS
- K123444 — LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER
- K120603 — VARILIFT -C
- K121463 — IMMUNOCAP ALLERGEN K82
- K122431 — HEARTSPAN STEERABLE INTRODUCER KIT
- K122890 — INION CPS ORBITAL PLATES
- K123067 — PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY
- K123269 — PROCEDURE REHEARSAL STUDIO
- K123349 — A-SCAN PLUS CONNECT
- K123358 — PACIFIC PLUS
- K123737 — BIOGRAPH MCT FAMILY
- K123873 — CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
- K123894 — GE ECHOPAC
- K123901 — TRACTUS TISSUEMAPPER REVIEWER APPLICATION
- K124048 — IMAGEQUBE
- K122156 — ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY
- K123135 — AXERA 2 ACCESS SYSTEM MODEL AXE200
- K123760 — MULTIPLE NAME
- K113375 — ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE
- K121326 — LANTOS 3D EAR SCANNER
- K121446 — BACT/ALERT PF PLUS CULTURE BOTTLE
- K121455 — BACT/ALERT FN PLUS CULTURE BOTTLE
- K121670 — MEDYSSEY CANNULATED PEDICLE SCREW
- K121860 — ESA615
- K122125 — ASA LASER SH1
- K122172 — SYSTEM 83 PLUS
- K122793 — LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET
- K122797 — ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW
- K123008 — RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN
- K123055 — SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
- K123096 — REPROCESSED VESSEL SEALER
- K123237 — ZERONA 2.0 LASER
- K123560 — VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM
- K123632 — 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
- K123917 — DECLIPSESPECT VIEWER
- K123956 — POWER LED 175
- K123966 — GLUCOSE METER-CHECK SOLUTION FOR BAYER
- K112120 — DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
- K121800 — POINT 500 HD POINT500C HD
- K122251 — VITRA MULTISPOT
- K122926 — SUREFLEX STEERABLE GUIDING SHEATH KIT
- K123071 — VASHE SKIN AND WOUND HYDROGEL
- K123304 — SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO
- K123325 — Medafor Direct Gas-Assisted Application System
- K123334 — REPROCESSED STEERABLE INTRODUCER
- DEN130012 — FERRISCAN R2-MRI ANALYSIS SYSTEM
- K112728 — HEPAIRX VENTILATING AIR PURIFIER
- K121810 — OSSEOSPEED ANGLED ABUTMENT EV
- K121964 — MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML
- K122290 — ENVITEC MYSIGN O OXYGEN MEASURING DEVICE
- K123281 — ACCULIF TL-PEEK CAGE
- K123310 — FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)
- K123401 — GAMMA3 AND T2 RECON TARGETING DEVICES
- K123579 — FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL
- K123857 — DURABLUE STERILIZATION WRAP
- K123982 — TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+
- K121269 — TBA
- K121461 — BACT/ALERT FA PLUS CULTURE BOTTLE
- K122995 — INTENSE PULSED LIGHT (IPL) SYSTEMS
- K123314 — AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE
- K123566 — SYNAPSE 3D COLON ANALYSIS
- K123577 — SYNGO.VIA MI WORKFLOWS
- K123718 — PERMASORB DISPOSABLE FIXATION DEVICE
- K123967 — CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS
- K120464 — INNESIS PEEK CAGE
- K121592 — POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
- K121739 — IVUE WITH NORMATIVE DATABASE
- K121762 — CARDIAC VX
- K122310 — GEMINUS FOSSA SPECIFIC PLATE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.