FDA 510(k) clearances — page 8
clearances on record, most recent first.
Clearances — page 8
701–800 of 176,428- K260588 — Cleerly LABS
- K261058 — CraniUS Plate
- K261205 — SPINEART Navigation Instrument System
- K261210 — Cleerly Plaque
- K261766 — CPS Locator 3D Plus Delivery Catheter
- K261770 — Suture Button Repair System
- K261829 — Profoject Dual-Safety Pen Needles
- K262200 — Stone Clear (BWSC-LP9-02)
- K262240 — SSPC NXT Delivery Catheter
- DEN250042 — CaRi-Heart
- K253450 — BodyTom Elite (NL4000)
- K253651 — Revi System
- K260303 — See-Mode Augmented Reporting Tool, Breast (SMART-B)
- K260326 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
- K260558 — Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more
- K261399 — ELISIO-HX
- K261412 — V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System +4 more
- K261427 — uMI Panvivo (uMI Panvivo M)
- K261430 — TruLift Expandable System
- K261511 — Xpert Ankle
- K250419 — Intimate Rose Pelvic Wand (Purple) +2 more
- K260529 — Air Compression Massager (HY-1165)
- K260835 — ARCHIMEDES Biodegradable Stent (Medium)
- K261105 — Powered Aventus Thrombectomy System
- K261211 — Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System
- K261310 — FlexTract Deflectable-Rotational Dilator Sheath Set
- K261759 — Euphora Rapid Exchange (RX) Balloon Dilatation Catheter
- K262201 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
- K262474 — ND Needle Guidance System
- K253576 — CorVista System® with PCWP Add-On
- K261367 — Corsano CardioWatch 287-2 System
- K253206 — METICULY Patient-specific CMF solution
- K260382 — MONARCH Platform (MON-000008)
- K252370 — GEN 4 JOY Wheelchair
- K253277 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
- K253452 — Accuro 3S
- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
- K253703 — RemunityPRO+ Pump for Remodulin® (treprostinil) Injection
- K253943 — Tiger 2 System
- K254180 — PerfusiX-Imaging
- K260192 — DIANA
- K260259 — DiscreetDuo Flow Wearable Breast Pump (Model S3)
- K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
- K260598 — 5 Wavelength LED Facemask (TN2508)
- K260948 — Air Compression Massager (EP30B001 I)
- K261014 — Accuro® 3S Needle Guide Kit
- K261024 — TMINI Miniature Robotic System
- K261027 — NOVEOS Specific IgE (sIgE) +5 more
- K261221 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
- K261267 — Careflux H60; Careflux H70; Careflux V500
- K261274 — EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes +1 more
- K261312 — Temporary Keratoprosthesis (QuickSet TKP)
- K261349 — SwiftMR
- K261364 — Atellica CH Acetaminophen 2 (ACTM)
- K261488 — OBSIDIO Conformable Embolic
- K261781 — Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60
- K261849 — VERAFEYE Imaging Catheter (VF-VIC-002)
- K262121 — Ion-L Navigated Instruments
- K262152 — VS-370CF, VS-370CT
- K262165 — FARADRIVE Steerable Sheath (M004PF21M402)
- K262290 — REMEDY POLY+PLUS SNAP FIT Acetabular Cup
- K262294 — dS FootAnkle 16Ch 1.5T +5 more
- K262383 — LumenCare Azure
- K262462 — TheraSphere 360 Y-90 Management Platform
- K251576 — Total Flow Medical Femoral Arterial (TFA) cannula
- K253041 — 3d Cage Cervical
- K253044 — RXiBreeze PAP System (RXiBreeze 20C)
- K253932 — FACEGYM Pro Device (HD-109)
- K254096 — VELMENI for DENTISTS (V4D) 3D
- K261081 — Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)
- K261082 — Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)
- K261136 — Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)
- K261272 — ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system
- K261644 — Perfadex Plus
- K261694 — CORE 300 Digital Stethoscope
- K261734 — Klassic Infection Spacer System
- K261748 — Dental Cone-beam Computed Tomography (mDX-15P Series)
- K261853 — Gepotidacin GEP 10 µg
- K262116 — TRUE METRIX Self Monitoring Blood Glucose System
- K262143 — ImageGrid StreamVue
- K253840 — STEDI Scan Device
- K254296 — Ossiclear (Ossiclear System)
- K260721 — Tornier Perform Advanced Glenoid
- K260804 — Anovo Surgical System (6Ne)
- K260964 — NanoZoomer S540MD Slide Scanner System
- K261113 — Op.n Spine Navigation and Robotic Guidance
- K261179 — AlphaTriPart - Monopolar MIC Instruments
- K262075 — Lapidus Screw Kit
- K262086 — PreludeSYNC Radial Compression Device
- K262094 — E3D-C Interbody System
- K262211 — Lancet
- DEN250068 — OTTAVA Robotic Surgical System
- K253770 — CardIQ Suite
- K253814 — Raney Clips Kit
- K260500 — ResolutionMD
- K260591 — NOVEOS Specific IgE (sIgE) +5 more
- K261406 — Versalock Proximal Tibial Plating System
- K261728 — One-Fil LC
- K261738 — Medical Thulium Fiber Laser Systems (UroFiber 150Q)
- K261775 — Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)
Data sourced from openFDA. This site is unofficial and independent of the FDA.