FDA 510(k) clearances — page 306
clearances on record, most recent first.
Clearances — page 306
30,501–30,600 of 175,699- K162076 — chromID MRSA
- K162080 — t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
- K162117 — NIRO-200NX DP
- K162145 — vRad PACS with Mammography
- K162274 — Solana Strep Complete Assay
- K162370 — syngo.via RT Image Suite
- K162386 — KATOR Suture Anchor
- K162443 — PowerPICC Provena Catheters
- K162695 — truFreeze System
- K162736 — Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT
- K151399 — Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow
- K153188 — Caremed patient cable and leadwires
- K160245 — Visco (olifilcon A) soft contact lens
- K161426 — NeoSpan Compression Staple Impant w/instruments
- K161697 — Acclarent NavWire Sinus Navigation Guidewire
- K161698 — Relieva UltirraNav Sinus Balloon Catheter
- K161701 — CARTO ENT System
- K161720 — Standard Clamp
- K161846 — Automatic Arm Bluetooth Blood Pressure Monitor
- K162060 — Ahmed Glaucoma Valve
- K151970 — KJ Mini Implant System
- K153784 — NOSOGARD FILTERS
- K160187 — Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
- K160294 — SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles
- K160313 — Xenco Medical Cervical Interbody System
- K160352 — MAGEC® Spinal Bracing and Distraction System
- K160442 — Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers
- K160541 — Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
- K160992 — HPM-6000
- K161295 — MiniBox +
- K161481 — Ambient HipVac 50 Wand with Integrated Finger Switches
- K161555 — KARL STORZ NAV1 Electromagnetic Navigation System
- K161773 — CapsoCam Plus (SV-3) Capsule Endoscope System
- K162027 — TRAcelet Compression Device
- K162061 — M.U.S.T. Pedicle Screw System
- K162317 — Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens
- K162474 — Artemis
- K162554 — Gentrix Surgical Matrix
- K162635 — Distal Radius Plating System
- K162687 — Paragon 2
- K153016 — aoni Natural Rubber Latex Condom
- K160181 — COLORADO THERAPEUTICS XENOGRAFT IMPLANT
- K160363 — OPTIMUS CMF SYSTEM
- K160847 — Rockwell Medical CitraPure Acid Concetrate
- K161010 — HICP200 Patient/Monitor Interconnect Cable
- K161422 — DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K161540 — Advanced Breast Template System
- K161674 — QuantumCam
- K161676 — Q13 SPIROLYSER®
- K162272 — Fluent inflation device
- K162445 — LiVac Retractor System
- K162629 — IQM Integral Quality Monitor (also IQM)
- K162660 — Green Smart (Model: PHT-35LHS)
- K160081 — TENS Electrodes
- K160199 — Advocate Insulin Pen Needles
- K160203 — ADAMANT ZIRCONIA DISC
- K160401 — Tyto Stethoscope
- K160706 — ReNew V Handpiece Laparoscopic Instruments
- K161016 — Z-Clamp ISP System
- K161073 — Klassic HD Hip System
- K161473 — Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
- K161797 — Avance Tubing, Avance Y-Connector, Avance ViewPad
- K161941 — Pulsaderm Acne Device
- K162065 — Ultrasound System SONIMAGE HS1
- K162593 — HDL-Cholesterol Gen.4
- K162597 — Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
- K151139 — EasyMap MAP Catheter
- K160074 — Rampart D Lumbar Interbody Fusion Device
- K160495 — VITROS® Automation Solutions
- K160559 — NOBLUS Ultrasound Diagnostic System
- K160643 — ENROUTE 0.014 Guidewire
- K161580 — Premier Sealant
- K161786 — ClearLumen II Thrombectomy System
- K161893 — Neuromonitoring Kit
- K162025 — IntelliSpace Portal Platform
- K162029 — 16ch T/R Knee Coil
- K162054 — Medtronic Temporary External Pacemaker 53401
- K162326 — Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
- K162584 — VersaOne Bladeless Trocar
- K162602 — NovoPen Echo
- K162622 — Fujifilm Endoscope Models EC-600HL and EC-600LS
- K161604 — OSSTEM Implant System
- K161960 — bk2300
- K162614 — Infinix, INFX-8000V, V6.35
- K153521 — IH Implant System
- K153577 — FREND Testosterone Test System
- K160268 — Fingertip Pulse Oximeter MD300CG11/MD300CG51
- K160279 — ANYVIEW-500R Fluoroscopic Mobile X-Ray System
- K160371 — NovaPACS
- K160782 — BracePaste Adhesive
- K161184 — iNSitu Total Hip System
- K161361 — HawkOne Directional Atherectomy System
- K161546 — R2P SlenGuide
- K161569 — Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws
- K161687 — D-10 Hemoglobin A1c Program
- K161714 — Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
- K161882 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K161886 — Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device
- K161912 — ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip
- K161981 — Olive Plus
Data sourced from openFDA. This site is unofficial and independent of the FDA.