FDA 510(k) clearances — page 329
clearances on record, most recent first.
Clearances — page 329
32,801–32,900 of 176,542- DEN150030 — KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
- K151588 — maxFit II Dental Implant System
- K151913 — MIM-Thin Client (mobile)
- K152493 — POGO Automatic Blood Glucose Monitoring System
- K152934 — MMS PTA Balloon Catheter
- K153407 — Stryker Neptune 3 Waste Management System
- K160285 — Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202
- K151357 — MIRI TL
- K152553 — CueSee Hypoxic
- K152701 — Matrix Mini ECG Monitor
- K153413 — PASS LP Spinal System
- K153590 — AvaDent Denture Base Material
- K153737 — OSTEOPAL plus
- K160019 — U80 Series Upper Arm Electronic Blood Pressure Monitor
- K160125 — Cascadia Interbody System
- K160177 — Gridlock Ankle Plating System
- K160216 — Revolution Spinal Fixation System
- K160227 — ACCENTO / HWA Dual/Single laser
- K160300 — MotoBand(TM) CP Implant System
- K160353 — MX50N(MX50YQS)
- K160432 — Anzai Respiratory Gating System
- K160633 — G3(TM) Active Plate(R) Small Fragment System
- K160689 — Reveal LINQ
- K160814 — Sydney IVF Sperm Cryopreservation Buffer
- K160914 — sterEOS Workstation
- K150914 — Dash-Topic Plus Cream
- K152059 — Disposable General Electrode
- K152077 — MaxiGen
- K152117 — Dropper hsCRP High Sensitivity CRP Control
- K152222 — NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs
- K152365 — AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System
- K153404 — Zavation Spinal System
- K153558 — Ventix Suture Anchor
- K153614 — PROBEAT-V and accessories
- K160142 — MINERAL OIL
- K160172 — Laparoscope Lens Shield Device
- K160206 — VirtuoSaph Plus Endoscopic Vessel Harvesting System
- K160249 — ULTRA Telescopes
- K160827 — Pantheris Catheter
- DEN140022 — GLAUCOMA COMPANION
- K160051 — NuVasive® Interfixated Interbody System
- K160440 — Leksell Gamma Knife Icon
- K160500 — Elite SPK, Compasso, Elite SPK Kit
- K160832 — Penumbra Smart Coil
- K151527 — Arthrex Univers Revers CA Heads and Adapters
- K153194 — VASOVIEW HemoPro Endoscopic Vessel Harvesting System
- K153638 — Bicortical Fixation Screw & Washer Nut System
- K153648 — Microcyn Plus Skin and Wound Hydrogel
- K153694 — Icare ic100
- K153698 — LumenR Tissue Retractor System
- K160126 — AIRO Computed Tomography (CT) X-ray System
- K160674 — Fujifilm Sonosite Vevo MD Imaging System
- K152563 — Pulse Oximeter (MD300M/MD300K2)
- K153192 — Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests
- K142263 — Applanation Tonometer
- K150372 — VERASENSE Knee System
- K150476 — Spectra S1Plus and Spectra S2 Plus
- K151120 — Simple T Pediatric Nasal Mask
- K151731 — Rainbow Paste Stain
- K151855 — SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber
- K151874 — BiNAPS Nasal Airflow and Snore Transducer +1 more
- K151922 — StimSox(TM) System
- K152075 — VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)
- K152590 — ACCU NEWS Drug Screening Test Card/Urine Cup
- K153222 — Leva Spacer System
- K153343 — MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit
- K153361 — Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
- K153501 — Bullfrog Micro-Infusion Device
- K153624 — Neodent Implant System
- K153655 — Accuryn Monitoring System
- K160195 — Forma System, Forma Light System
- K160749 — CRIT-LINE III Blood Chamber II
- K160788 — RIOScan (RPS500)
- K160792 — Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound
- K143477 — Nitrile Patient Examination gloves, Powderfree, Blue color
- K143605 — Nutraseb Facial Cream
- K152111 — Symmetry Surgical Quad-Lock Container System
- K152364 — uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS
- K152959 — Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes
- K153251 — Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff
- K153696 — Chattanooga Revolution Wireless
- K160346 — MX30N(MX30TQS)
- K160348 — CX30N (CX30PQX)
- K160716 — The Nanostim Introducer Kit
- K160968 — iPulse SmoothSkin Gold Hair Removal Device
- K143578 — SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer
- K151608 — 4plus6Line Abutment System
- K151704 — Diplomat® Spinal System
- K151953 — A&D Medical TM-2657 Family of Digital Blood Pressure Monitors
- K152329 — Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System
- K152538 — JRP Wound Spreader
- K153038 — Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
- K153061 — Juno VPAP ST-A
- K153174 — Ketac Universal Aplicap
- K153255 — Aero Chrome* Breathable Performance Surgical Gown
- K153419 — NuVasive CoRoent Thoracolumbar System
- K153653 — DICOM Viewer
- K160021 — Varian Sterilization Boxes
- K160608 — NormaTec Pulse and NormaTec Pulse Pro
- K160693 — Neptune E-SEP Smoke Evacuation Pencil
Data sourced from openFDA. This site is unofficial and independent of the FDA.