FDA 510(k) clearances — page 304
clearances on record, most recent first.
Clearances — page 304
30,301–30,400 of 176,542- K170355 — RayStation 6
- K170420 — n!ce Glass Ceramic Blocks for Amann Girrbach
- K162026 — EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions
- K162383 — Cadwell Sierra Summit, Cadwell Sierra Ascent
- K163284 — syngo. CT Neuro Perfusion
- K170332 — DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
- K161655 — On1 Concept
- K162018 — Surface Applicator Set
- K162753 — RTC 26-C Inline Aerosol Adapter
- K162837 — Smart Laser Indirect Ophthalmoscope (LIO) +1 more
- K163008 — CareLink SmartSync Device Manager - Pacing System Analyzer
- K163038 — EPIC Extremity Snap-Off Screw
- K163234 — Biograph mMR with syngo MR E11P system software
- K163245 — Virtual Occupational Therapy Application (VOTA)
- K163282 — Apex Dental Sensors
- K163543 — Biomet Fusion System
- K163709 — FIRMap Catheter
- K170008 — Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
- K170105 — Jac-Cell Medic testers
- K170283 — BD Nexiva Diffusics Closed IV Catheter System
- K161853 — proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
- K162903 — Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
- K162982 — Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
- K163032 — Kyphon Xpede Bone Cement
- K163191 — ComfortGuard Surgical Gown, i600, Film Reinforced
- K163591 — BD PosiFlush Heparin Lock Flush Syringe
- K170373 — Flextra Steerable Introducer
- K160358 — DT-100
- K160857 — HF 718BD X-Ray System
- K161371 — Sonoma Fifth Metatarsal Repair System
- K161372 — The Red Head Collection Device, The Jordy Connection System
- K161484 — ZIIP Device
- K161579 — Watch-PAT200U
- K161859 — MagnetOs
- K161860 — TG-970P CO2 Sensor Kit
- K162071 — IllumiFlow Laser Cap
- K162073 — Dental Implants OKTAGON Tissue Level and Bone Level
- K162393 — The ViewRay (MRIdian) Linac System
- K162752 — ARTIA Reconstructive Tissue Matrix Perforated
- K162771 — EkoSonic Endovascular System with Control Unit 4.0
- K162888 — Cercon
- K162916 — 3NT endoscopy system
- K162989 — Rusch Simplastic Foley Catheters
- K163056 — Revolution Spinal Fixation System
- K163480 — Renamel NANO +plus
- K163513 — Arrow Endurance Extended Dwell Peripheral Catheter System
- K170218 — Vesco Medical NRFit Tip Syringes
- K170257 — Sydney IVF Culture Oil
- DEN160032 — Accelerate Pheno system, Accelerate Phenotest BC Kit
- K160837 — MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM
- K161099 — Powder Free Nitrile Examination Gloves, Black
- K161316 — George King Coumadin Plasma
- K161335 — Dual Top Screw System
- K161607 — VISULUX
- K161693 — Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis
- K161848 — Family of Steam sterilizers B17 B22 Series
- K161907 — Pressure Therapy System
- K162484 — Lung Nodule Assessment and Comparison Option (LNA)
- K162670 — RSM 1824C with RConsole1
- K162827 — VIDAS B.R.A.H.M.S. PCT (PCT)
- K162855 — Reveal LINQ
- K162922 — GalaFORM 3D
- K162926 — Air-Powered Handpieces and Handpiece Attachments
- K162937 — Stryker OrthoMap Versatile Hip System
- K163168 — Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)
- K163279 — Medtronic Transportation/Sterilization Cassettes
- K163322 — TZ SKULL PIN Adult
- K163688 — Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10
- K170209 — ImPACT
- K170240 — Truliant Femoral Components
- K170265 — GRAVITYTM PEEK-OPTIMA Suture Anchor
- K151834 — BEMER Classic Set, BEMER Pro-Set
- K152022 — SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT Spacers, ALTERA Spacers, MAGNIFY Spacers, InterContinental® Plate-Spacer
- K161500 — MEG-TORQ
- K161534 — EasyOne Pro Respiratory Analysis System
- K161926 — ND YAG Q-switch Laser Therapy Machine
- K162795 — PROPHECY INVISION Preoperative Navigation Alignment System
- K162800 — BLUEPRINT Patient Specific Instrumentation
- K162911 — Sofia RSV FIA on Sofia 2 analyzer
- K162929 — Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker
- K163041 — Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E
- K163126 — Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)
- K163298 — Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL
- K163535 — my Patch sl
- K163691 — HS70A Diagnostic Ultrasound System
- K170202 — Aquarius 8600
- K161120 — SMR TT Metal Back Glenoid, Bone Graft instruments
- K161894 — SurgTech Trauma System
- K161987 — UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure
- K162032 — Arrowhead Mini-Rail Fixator
- K162391 — AlignMATE Lapidus Arthrodesis System
- K162841 — VariAx Distal Radius Plating System, VariAx 2 System
- K163045 — Omron HEM-6400T-Z Wrist Blood Pressure Monitor
- K163051 — ClearLumen II Peripheral Thrombectomy System
- K163091 — VibraPEP
- K163273 — TRU Legionella
- K163317 — ELECTROmatic
- K170258 — SpeedLyser Infusion Catheter Kit
- K162565 — VIA 17 Microcatheter
- K163272 — AXIOS Stent and Electrocautery Enhanced Delivery System
Data sourced from openFDA. This site is unofficial and independent of the FDA.