FDA 510(k) clearances — page 314
clearances on record, most recent first.
Clearances — page 314
31,301–31,400 of 176,542- K152533 — Xonrid Gel
- K160143 — ClearVision ExamVue Flat Panel Detector
- K160297 — Tuohy NRFit
- K160312 — FRAXIS DUO
- K160488 — Cutera enlighten III Laser System
- K160519 — Link Abutment for CEREC
- K160882 — PaX-i3D Green Premium (Model: PCT-90LH)
- K160974 — Gammex Cut-Resistant Glove Liner
- K161497 — Dental Implants and Abutments
- K161520 — ELEOS Limb Salvage System
- K161725 — Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
- K162419 — FIREFLY® Pedicle Screw Navigation Guide
- K162422 — Klassic Knee System
- K162437 — Codman EDS3 CSF External Drainage System
- K162513 — Arterys Software v2.0
- K162715 — SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene +1 more
- K153332 — ETIII SA Fixture System (O3.2mm)
- K160121 — CorPath GRX System
- K160295 — SPROTTE NRFit, Quincke NRFit
- K160296 — SPROTTE SPECIAL NRFit
- K160316 — SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles
- K160885 — HemosIL D-Dimer HS
- K161065 — ColpoWave Colpotomizer and CerviGrip Uterine Manipulator
- K161605 — Smart External Drain (SED) System
- K161718 — MaxBlend 2, MaxBlend Lite
- K161822 — Torcon NB Advantage Catheters
- K162169 — EdgeOne CO2 Laser
- K162256 — Klassic Femur, Porous, Klassic Tibial Baseplate, Porous
- K162367 — Erisma® LP MIS
- K162750 — Libra Pedicle Screw System
- K160583 — REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
- K161194 — PLEX Elite 9000 SS-OCT
- K161351 — NanoBone SBX Putty
- K161393 — Reprocessed Orbiter ST Steerable Diagnostic EP Catheter
- K161830 — Zimmer M/L Taper Hip Prosthesis
- K162138 — NuVasive CoRoent Small Ti-C System
- K162250 — FortiBridge Anterior Cervical Plate System
- K162469 — CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps
- K162514 — Multichem A1c
- K162762 — NeuroBlate System
- K160260 — Tempo Temporary Pacing Lead
- K161042 — CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
- K161973 — G-scan Brio, S-scan
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.