FDA 510(k) clearances — page 289
clearances on record, most recent first.
Clearances — page 289
28,801–28,900 of 175,699- K170370 — ULTRASHAPE POWER SYSTEM
- K170784 — PNEUMOCLEAR
- K171137 — EVS 2430W, EVS 2430GW
- K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test
- K161261 — Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase
- K162392 — Avazzia
- K170199 — Unity Network ID
- K170228 — Belimed Steam Sterilizer MST-H TOP 5000
- K170401 — Piccolo Composite® Plate System
- K171072 — N Latex Cystatin C; N Protein Standard UY
- K171083 — iChemVELOCITY Automated Urine Chemistry System
- K171119 — GM85
- K160667 — Anybattery C2 Rechargeable Battery
- K161950 — Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
- K161961 — UniTex Non-Sterile, Powder-Free, Latex Examination Glove
- K162328 — Winner Transfer Wheelchair
- K162566 — AIK Sterile Acupuncture Needles for Single Use
- K162667 — Kitazato IUI Catheter
- K163131 — A-dec NLZ Electric Motor System
- K163250 — Longitudinal Brain Imaging (LoBI) application
- K163276 — Fully Automatic Electronic Blood Pressure Monitor
- K163576 — GORE SYNECOR Preperitoneal Biomaterial
- K163622 — Lung Vision
- K170135 — TREFOIL System
- K170205 — Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
- K170382 — Arthrex Compression Screws
- K170413 — BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
- K170419 — SurgiCase Viewer
- K170491 — Solana C. difficile Assay
- K170581 — Mako Total Knee Application
- K170584 — Mako Partial Knee Application
- K170647 — Connector System
- K170648 — ANTHEM CR Total Knee System
- K170679 — CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems
- K170990 — Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator
- K171085 — GMR40
- K162125 — MALUC Total Hip Arthroplasty System
- K162348 — ABCcolla Collagen Matrix
- K163476 — Lubricity
- K170594 — I.B.S. osteosynthesis screws
- K170650 — Orthofix TrueLok Hexapod System (TL-HEX) V2.0
- K171080 — ALP IFCC Gen.2
- K171097 — MOJAVE Expandable Interbody System
- K162131 — ExSpiron 1Xi
- K163117 — Alpha Pure
- K163382 — Oxitone 1000
- K163606 — Digital Blood Pressure Monitor-Automatic Upper Arm Style
- K170342 — Ocata Anterior Cervical System
- K170393 — Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)
- K170469 — NxStage System One Plus
- K170831 — EpiAccess System
- K171022 — Ablation Confirmation
- K171081 — Guider Catheter Introducer
- K171096 — Fujifilm Diathermic Slitter (FlushKnife)
- K151562 — Resultz Lice & Egg Removal Kit
- K161938 — Fingertip Pulse Oximeter
- K162594 — Craniomaxillofacial Distraction System (CMFD)
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.