FDA 510(k) clearances — page 298
clearances on record, most recent first.
Clearances — page 298
29,701–29,800 of 176,542- K162734 — CreoDent Solidex Customized Abutment
- K163327 — Precifit Medical Kirschner Wires
- K163670 — Rampart One Lumbar Interbody Fusion Device
- K170111 — Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37
- K170180 — Will3D
- K170363 — Ceribell Pocket EEG Device
- K170734 — Venus Silk.expert
- K170740 — GORE VIABIL Short Wire Biliary Endoprosthesis
- K170744 — Adhesive Electrodes
- K170771 — VariAx 2 Foot System
- K171094 — Thermi Reusable Non-invasive RF Electrode
- DEN160033 — ARK Voriconazole II Assay Test System
- K160950 — MINISCAV
- K161770 — Rusch Silicone Foley Catheter
- K162449 — Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
- K163070 — Kent Camera
- K163204 — A08 Power wheelchair
- K163293 — Colink Plating System
- K163315 — Internal Distraction - Sterile
- K163370 — ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE
- K163665 — MATRx plus
- K163672 — Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor
- K170068 — Softcure 96
- K170152 — POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
- K170475 — SICAGE System
- K170576 — LENSAR Laser System - fs 3D (LLS-fs 3D)
- K170789 — In Reach
- K171076 — Medical Video Endoscope System
- K171082 — Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System
- K162207 — Restore Moisturizing Vaginal Lubricant
- K162254 — Cedic Enteral ENFit Transition Connectors
- K162330 — Flex Robotic System and Flex Colorectal Drive
- K162496 — Foundation 3D Interbody
- K163238 — Eclipse Kiss Zirconia
- K163468 — Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
- K163615 — Snowden-Pencer MicroLap 3mm Laparoscopic Instruments
- K170543 — VIPER PRIME Screws with Fenestrations
- K171130 — Nucleus Image Management System
- K171141 — Arthrex SwiveLock Anchors
- K162248 — Asahi ViE-U Series Dialyzer
- K162263 — Optilite Rheumatoid Factor Kit
- K162523 — The IQool System
- K162756 — PHAKOS Disposable Retinal Cryo Probe
- K162952 — C.T.M. Mobility Scooter
- K163481 — HALF DOME Posterior Lumbar Interbody System
- K163530 — PrisMax Control Unit
- K163640 — QZA and RS Dental Implant Systems
- K163683 — A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor
- K170107 — Surgi Max Ultra
- K170269 — Hee HR Mini
- K170440 — KISSloc Suture System
- K170718 — Iridex TruFocus LIO Premiere
- K170977 — SURESHOT Distal Targeting System V4.0 Trauma Interface
- K171005 — Silhouette Featherlift
- K160781 — Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
- K161790 — iGlucose Blood Glucose Monitoring System
- K162041 — Airworks Nebulizer pe1200m
- K162380 — Locking Plate System
- K163621 — Vitoss Bioactive (BA) Injectable
- K163626 — ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
- K170049 — AssureTech Panel Dip Test, AssureTech Quick Cup Test
- K170108 — Xultan 5.5 Pedicle Screw System
- K170141 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
- K170308 — BD MAX Extended Enteric Bacterial Panel, BD MAX System
- K170360 — NAVIO
- K170364 — Collagen Meniscus Implant XL
- K171098 — AXIS Image Management System
- K162266 — The Cranial Fusion System
- K162303 — REDAPT Sleeved Monolithic Revision Stems
- K162620 — Remel Spectra ESBL
- K162647 — NuVasive NuvaLine Mobile App
- K162751 — Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider
- K162825 — CAPTIVATE Compression Screws
- K163119 — NaviSuite SSI Edition
- K163707 — NuVasive CoRoent Ti-C System
- K170011 — StealthStation S8 Spine Software v1.0.0
- K170114 — MagVita TMS Therapy - w/MagPro R20
- K170291 — IontoDC
- K170294 — VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4x 6) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6x8) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6x10) Oval
- K170334 — XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack
- K170733 — ScanX Intraoral View
- K170777 — Bovie J-Plasma Precise FLEX Handpiece
- K170975 — Televere Digital Imaging System
- K170145 — Digital TENS Unit
- K161596 — Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
- K161724 — Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)
- K161857 — Salvin Tenting Screw System
- K162120 — Scope-Assist Flushing Sink
- K162159 — VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing
- K162200 — Randox RX Daytona Plus Magnesium (MG)
- K162258 — Self Sealing Sterilization Pouches
- K162319 — BabyDance Fertility Lubricant
- K162460 — WAVi Headset and WAVi eSoc Single Use Electrode Contacts
- K162679 — IOB Temperature Management System
- K162945 — VERIFY ASSERT STEAM Process Challenge Device
- K163358 — Introcan Safety 3 Closed IV Catheter
- K163667 — RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack)
- K170070 — VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles
- K170273 — Z-DOSE29
- K170280 — Smith & Nephew SURESHOT Distal Targeting System V4.0
Data sourced from openFDA. This site is unofficial and independent of the FDA.