FDA 510(k) clearances — page 363
clearances on record, most recent first.
Clearances — page 363
36,201–36,300 of 175,770- K141054 — DISTAL ACCESS TORQUE DEVICE
- K141213 — AMERIWATER OZONE DISINFECTION SYSTEM
- K141463 — LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS
- K141810 — BD BACTEC PLUS ANAEROBIC/F (PLASTIC)
- K142343 — Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored)
- K142683 — 12 mm Endoscopes and Accessories
- K142951 — MD210C3 21.3 Diagnostic Imaging LCD Monitor
- K143125 — Orthofix True Lok Hexapod System VI.3
- K143206 — AmpliVue Bordetella Assay
- K143254 — eSie Apps Suite
- K140224 — EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)
- K141925 — TOTAL PROTEIN URINE/CSF GEN.3
- K142126 — EP NAVIGATOR REL. 5.0
- K142547 — Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm
- K143208 — Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit
- K143264 — H60 V2.00 Diagnostic Ultrasound System
- K140665 — GenPrime Snap-Top Split Key Cup
- K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.
- K141507 — TWO SKIN TREATMENT SYSTEM
- K141557 — HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR
- K141760 — ORTHOFIX GALAXY WRIST
- K141795 — BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500
- K142264 — Valeo C Spacer System, Valeo II C IBF Device
- K142433 — Hospira Extension Set
- K132313 — PESSARY
- K140705 — NAVIGABLE BRAIN BIOPSY CANNULA SET
- K140838 — IV ADMINISTRATION SET WITH HAND PUMP
- K140847 — CARDIOSPY ECG HOLTER SYSTEMS
- 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; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category)
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.