FDA 510(k) clearances — page 259
clearances on record, most recent first.
Clearances — page 259
25,801–25,900 of 175,699- K173615 — Stryker Universal Select Sterilization Tray System
- K173661 — Wingman 35 Crossing Catheter
- K173964 — OVOMotion Shoulder Arthroplasty System
- K180081 — RAILWAY Sheathless Access System
- K180836 — Genistrong
- K180851 — VERTEX Reconstruction System
- K172288 — Fusion OMNI Sphincterotome
- K172610 — THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S
- K172735 — WR19 System
- K173317 — DiLumen C2; DiLumen Tool Mount
- K173614 — Penumbra Coil 400, Ruby Coil System, POD System
- K173816 — NM/CT 850, NM/CT 860
- K180078 — Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
- K180146 — KARL STORZ ICG Imaging System
- K180353 — Diode laser hair removal device
- K180416 — ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
- K180458 — FOCUS Pedicle Screw System
- K180588 — FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device
- K180723 — PreludeSYNC DISTAL Radial Compression System
- K180914 — Aesculap Slim Clip Applier
- K171603 — Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set
- K172727 — Hemoclip
- K173226 — CardiMax Electrocardiograph
- K173726 — ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut
- K173935 — Mediant Anterior Cervical Plating System
- K180096 — GDT-1000 System
- K180126 — SOZO
- K162499 — Best Instruminal Applicator
- K170463 — KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
- K170761 — LIGHTSonic BUBM
- K170901 — ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
- K171326 — Piezosurgery White
- K171562 — Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
- K172143 — uMI 780 PET/CT System
- K172930 — mCare Powder-free Blue Nitrile Examination Gloves
- K173103 — Pivet and Soft-Pass Embryo Transfer Catheter Sets
- K173371 — VisuMax Femtosecond Laser
- K173606 — SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device
- K173632 — SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO
- K173692 — D-Actor 200 Vibration Massage System
- K173934 — Reza Band, Reflux Band
- K180305 — Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)
- K180408 — U60 Diagnostic Ultrasound System
- K180667 — SmartGrid
- K180699 — Voyant Open Fusion Device
- K180704 — SonoSite iViz Ultrasound System
- K172155 — StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing
- K172201 — Atellica IM Folate Assay
- K172315 — Straub Endovascular System
- K173515 — Admiral Xtreme
- K180549 — ZED Link
- K180567 — C3 Wave System
- K180651 — Uroview FD II
- K180666 — 48CH Head Coil
- K180689 — Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device
- K180795 — JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
- DEN180001 — IDx-DR
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.