FDA 510(k) clearances — page 371
clearances on record, most recent first.
Clearances — page 371
37,001–37,100 of 176,542- K140931 — IGROW II HAIR GROWTH SYSTEM
- K141611 — LYTHOS DIGITAL IMPRESSION SYSTEM
- K141681 — SYSMEX XN SERIES
- K141701 — I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]
- K141955 — XN CAL PF
- K141957 — XN CHECK BF
- K141962 — XN CAL
- K141964 — XN CHECK
- K142052 — ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT
- K142142 — QUALITY REPORTS
- K142361 — Discovery MR750 3.0T
- K142365 — Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack
- K142379 — Passeo-35 PTA Catheter
- K142388 — Neo Total Knee System
- K142409 — Vinyl Co-Polymer Powder Free Examination Gloves
- K142431 — WaterProof PROFILER
- K142671 — ONEFIT HIP PLANNER
- K142676 — Siemens 3.0T PROCURE Array Coil
- K142758 — ADVIA Centaur HAV total assay
- K143025 — TOTAL COMPRESSION PLATING SYSTEM
- K143194 — ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM)
- K143205 — Viscoelastic Injector
- K143221 — Schoelly Laparoscope
- K140285 — B TRAVELSAVVY SHARPS CONTAINER
- K140657 — CUROS RED PORT PROTECTOR
- K141064 — VESOFLOW PLUS DVT COMPRESSION DEVICE
- K141092 — MARK3
- K141105 — PULSE OXIMETER
- K141613 — GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES
- K141632 — ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM
- K142122 — RADAR VASCULAR COMPRESSION DEVICE
- K142168 — NATURE'S BOND 600 AND NATURE'S BOND 603
- K142728 — ActiveCare+SFT +2 more
- K143079 — Endovascular Stent Planning Software
- K143145 — SafeAir Smoke Pencil
- K133373 — CLEARVIEW
- K133496 — X TWIN SYSTEM
- K133502 — 5000Z FIREFLY SYSTEM
- K133924 — ENDOLUMINAL OCCLUSION SYSTEM (EOS)
- K140589 — STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR
- K140920 — SYNGO.CT COLONOGRAPHY
- K140926 — INMODE WMFACE DEVICE
- K141020 — SURVEYOR S4 MOBILE MONITOR
- K141279 — WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
- K141287 — HUIKANG NITRILE POWDER FREE PATIENT EXAM GLOVES, BLUE COLOR
- K141412 — STERILUCENT SELF-SEAL STERILIZATION POUCH
- K141529 — ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER
- K141978 — MAXPOWER RELIEF
- K142288 — MAC 800 Resting ECG Analysis System
- K142672 — AliveCor Heart Monitor
- K142915 — ZOLL X Series
- K143057 — M3290B Philips IntelliVue Information Center iX
- K143144 — ST AIA-PACK PROG II Calibrator Set
- K143217 — 12 mm & Stapler Bladeless Obturators
- K140290 — STOPLOSS JONES TUBE
- K140296 — CLEARLUMEN THROMBECTOMY SYSTEM
- K140796 — MEDUSA VASCULAR PLUG,
- K141282 — PGS 5.5 MM CANNULATED PEDICLE SCREW
- K141862 — HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE
- K142069 — GMK EXTENSION
- K142310 — Stryker Infrared Fluorescence (IRF) Imaging System
- K142340 — Infrared Therapy System
- K142803 — Skintact, various other tradenames
- K143164 — ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
- K133994 — SIVR56-T KIT
- K141135 — JULIET LL
- K142285 — AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz
- K142471 — Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip
- K142521 — Synapse 3D Liver and Kidney Analysis
- K142573 — HairMax LaserComb, HairMax LaserComb
- K142580 — Chemtrue Multi-Panel DOA DIP Card Tests
- K142591 — CD HORIZON Spinal System
- K142917 — BP652N (HEM-6300-Z)
- K142973 — Resolution Clip
- K143141 — CD HORIZON Spinal System
- K140041 — ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM
- K142594 — nva, nvp, nvt
- K143066 — Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers
- DEN130045 — HEARTFLOW FFRCT
- K133434 — GENESIS II
- K140842 — DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART
- K140859 — DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT
- K140884 — SYMETREX LONG TERM HEMODIALYSIS CATHETER
- K141158 — APEX
- K141408 — RESOLVE BILIARY LOCKING DRAINAGE CATHETER
- K141741 — AQUILION PRIME, V6.00
- K142029 — MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
- K142501 — Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
- K142695 — Cytosponge Cell Collection Device
- K142938 — G3 Active Plate Large Fragment System
- K143089 — WS80A Diagnostic Ultrasound System
- K143091 — Surgisleeve Wound Protector
- K133989 — AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
- K140382 — AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY
- K140535 — PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
- K140768 — TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT
- K141231 — ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY
- K141333 — ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
- K141523 — ALLY UPS
- K141537 — IN:C2 SPINAL FIXATION SYSTME
Data sourced from openFDA. This site is unofficial and independent of the FDA.