FDA 510(k) clearances — page 268
clearances on record, most recent first.
Clearances — page 268
26,701–26,800 of 176,542- K172047 — Riva Star
- K172187 — Inno-Hydrowire
- K172495 — Reform® POCT System
- K173686 — Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
- K173859 — HEALIX ADVANCE Anchor with DYNACORD Suture
- K173860 — s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
- K173880 — Corin TriFit CF Hip Stem
- K180121 — Rafugen DBM
- K180318 — PET Digital Gating
- K180744 — Stablyx CMC Arthroplasty Implant System
- DEN170001 — Precision Flow® HVNI
- K170776 — DTI-1 SLA IMPLANT SYSTEM
- K171379 — Digital Automatic Wrist Blood Pressure Monitor MD4300
- K172206 — NAJA Ligament Correction System
- K172967 — Mercury® Spinal System
- K173384 — BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
- K180233 — Eviva Stereotactic Guided Breast Biopsy System
- K180299 — ACUVUE OASYS (senofilcon A) with Photochromic Additive
- K180301 — AXIS 5.5 Lumbar Pedicle Screw System
- K180398 — Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal
- K180530 — Imager II Urology Torque Catheter
- K171409 — OT EQUATOR
- K172151 — Hysteroscopy System
- K173386 — Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs
- K173889 — Medline Cautery Electrode (PTFE)
- K180083 — Silicone Personal Lubricant, ALL-IN-ONE
- K180208 — Disposable Endoscopic Trocar
- K180329 — ClotTriever Thrombectomy System
- K180372 — Aurora Evacuator
- K170570 — Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung
- K172173 — DiaSpect Tm, DiaSpect Tm Cuvettes
- K172956 — Medicant Mucosal Atomizer
- K173525 — NovoGro
- K173767 — A. L. P. S. Clavicle Plating System
- K173775 — Clench Compression Staple
- K180033 — 8mm Monopolar Curved Scissors
- K180080 — FIBERGRAFT BG Matrix Bone Graft Substitute
- K180271 — NAVIO Surgical System (NAVIO system)
- K180324 — Patriot Spinal Fixation System
- K180584 — Viveve RF System, Secure
- K180614 — PICO Single Use Negative Pressure Wound Therapy System
- K180630 — PTFE SURGICAL SUTURE
- K162408 — Nano Varnish, Plaquit, Lightpaint on Surface
- K171713 — Neodent Instrument Kits
- K171847 — Corin Optimized Positioning System (OPS) Plan
- K172014 — Wedge Microcatheter
- K172156 — PENTAX Medical EPK-3000 Video Imaging System
- K172368 — Bipolar Micro-Coagulation Forceps
- K172998 — uWS-MI
- K173207 — SIC invent Dental Implant Systems
- K173333 — GORE ENFORM Biomaterial
- K173526 — SENTIO MMG Gen 2
- K173586 — VAMP Venous/Arterial Blood Management Protection System
- K173867 — Axis Anterior Cervical Plate System
- K173897 — syngo.via MI Workflows
- K180089 — Medacta Shoulder System Short Humeral Diaphysis
- K180125 — PowerLook Density Assessment Software
- K180344 — TheraCal DC
- K180349 — AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
- K180376 — K2M Patient Specific Rods
- K180378 — Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
- K180589 — DR 800 with MUSICA Dynamic
- K180694 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
- K172141 — Pulse Oximeter
- K172239 — SIMPLANT 18
- K172963 — Master-Frank N95 Particulate Respirator
- K173072 — Algidex Ag Silver Alginate Wound Dressing
- K173074 — ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor
- K173079 — Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
- K173597 — Scenium VE20 Software
- K173699 — The Pump by Babyation
- K180088 — TrapLiner catheter
- K180339 — Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL
- K180342 — SYSTEM 1E Liquid Chemical Sterilant Processing System
- K180561 — MobileX Portable X-ray System
- K180571 — GammaPod
- K180595 — SciMoCa
- K180637 — leva Pelvic Floor Trainer
- DEN170047 — Curetis Unyvero LRT Application
- K172630 — Kisses Plus Implant System
- K172635 — High-Flo Silver Polyethylene Catheter
- K173362 — DSM Biomedical Calcium Phosphate Cement
- K173506 — LigaPASS
- K173885 — Genesys Spine Binary Lumbar Plate System
- K173958 — OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens
- K180243 — Infinity-Lock Button System
- K180320 — dpl IIa Panel
- K180503 — PRECICE STRYDE System
- K180566 — Unite Connect for Clinical Systems
- K180597 — AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO
- K180677 — Surefire Spark Infusion System
- K171692 — Instrument basket, for EndoEYE
- K172382 — GC Fuji Direct
- K173639 — Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax
- K173669 — K-D Balance
- K173896 — Microcyn Antimicrobial Hydrogel
- K180210 — CREO® Stabilization System
- K180586 — Varian Head Frame
- K170608 — UF(II) Implant System
- K171857 — AMSure® Enteral Feeding Syringe with ENFit Tip
Data sourced from openFDA. This site is unofficial and independent of the FDA.