FDA 510(k) clearances — page 6
clearances on record, most recent first.
Clearances — page 6
501–600 of 176,428- K260242 — CPETWise Platform
- K260579 — Infinity® Acute Care System (IACS) VG8.1
- K260817 — MIRA Surgical System
- K261049 — SCALA® TL
- K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
- K262113 — HardyDisk AST Tebipenem 10µg (TBP10)
- K262506 — Remex Spine Surgery Navigation - Universal Instruments
- K262515 — Kneu Platform (V2)
- DEN250046 — Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US)
- K253240 — PrecivityAD2 Test
- K253431 — Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)
- K254213 — Pascall Sensor Unit (PSU1)
- K260209 — ENDOFLATOR+; Smart Smoke Evacuation
- K260463 — ZEROS Dental Implant System
- K260799 — Nipro Dry Acid Concentrate Mixer
- K261083 — Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)
- K261413 — EXTRON 3; EXTRON 6
- K261686 — Elecsys Phospho-Tau (217P) Plasma
- K261964 — ECHOLASER X4
- K262070 — Diode Laser Therapy Systems (DL612A)
- K262537 — Versalock Sterile Plating System
- K262622 — Swoop® Portable MR Imaging® System
- K254071 — p17 XR Microcatheter
- K254256 — LUOFUCON® Wound Matrix
- K260266 — Tympendi (810)
- K260794 — NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR
- K260984 — HERizon RD5 Resecting Device (5FR1PK); HERizon RD5 Resecting Device - 5 pack (5FR5PK)
- K261641 — Lower Limb AI (LLAI)
- K262135 — Lancing device
- K262479 — TearCare System
- K262489 — BluEX Cervical Expandable Cage System
- K262729 — TeKBrace Solo Soft Tissue Reinforcement Device
- K254250 — MagicScan-1.5, GreenMR Serenity 1.5T
- K260137 — KLS Martin IPS Oral-Max Implants - MR Conditional +3 more
- K260224 — MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)
- K261500 — KBA3D (v2.4.0)
- K260563 — CN-Suite
- K253562 — medilogFD
- K253747 — Disposable Pen Injector (KXYC-03C02, KXYC-03A03)
- K260171 — Portable Oxygen Concentrator (PO1 5B, PO1 6B)
- K260374 — Empatica Health Monitoring Platform for Parkinson's Disease Monitoring +5 more
- K260438 — Vital Signs Monitor (CLEO2)
- K260559 — NHanceIT
- K260898 — Transpara (2.1.0)
- K261228 — QuickVision Ultimate rTMS
- K261428 — NC Euphora Rapid Exchange Balloon Dilatation Catheter
- K261646 — Redermax® Antibacterial Wound Matrix
- K261890 — 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®
- K262419 — MICRUSFRAME (19+ models)
- K262424 — Willow 12 Guidewire
- K262449 — AdvaView
- K262452 — AutoContour (RADAC V6)
- K262552 — Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
- K262571 — EnCor EnCompass Breast Biopsy and Tissue Removal System
- K262639 — BAGUERA® C Cervical Disc Surgical Instruments
- K253425 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)
- K253790 — High Intensity Focused Electromagnetic Stimulation Device (FE60)
- K253795 — MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution
- K253808 — AIR Recon DL
- K254201 — Any-Cem
- K260211 — Dashboard (P007000)
- K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM
- K260413 — Levo Gen 2 Tinnitus Therapy System
- K260907 — BIS Advance pEEG Module
- K261061 — BP Go (BPP-855)
- K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- K261499 — TrachFlush
- K261626 — UltraPrint Flexible Denture UV
- K262398 — CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set
- K251641 — GF-310R Multigas Unit (GF-310R)
- K253417 — Masimo Root Monitoring System
- K253846 — Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02) +2 more
- K260086 — CadAI-B Dx
- K260944 — ManaCold Compression System
- K261170 — BA-004CC
- K261916 — NeuroQuant PET
- K262344 — Large Compression Screws
- K262391 — APRO 35 Swift Catheter and Alembic Aspiration Tubing
- K262392 — APRO 35 Swift Catheter
- K262399 — Millipede System
- K262406 — EluPro Antibiotic-Eluting BioEnvelope
- K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)
- K253665 — Vashe Plus Antimicrobial Solution
- K253985 — INNOVANCE® D-Dimer 2.0 (SMN 10873803)
- K261115 — VR® Personal Protective Level 4 Gown (VR Gowns)
- K261398 — Dexter L6 System
- K261841 — Q Switched Nd:YAG Laser machine (QLQW-01)
- K262472 — Stelo Glucose Biosensor System
- K253468 — Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A)
- K253528 — Atellica IM CA 19-9 II
- K253794 — Prostate Core
- K254036 — Novii+ Wireless Patch System
- K254069 — Hemoclip (511 series, 543 series)
- K254143 — EM-TECH Passive Ultrasound Probe Strap
- K260094 — Mobility Scooter (W3465, W3902 (S50 Carbon))
- K260165 — Unimpregnated Central Venous Catheter
- K260176 — Mobility Scooter (W3483, W3483A)
- K261576 — Icona Hip Stem
- K261602 — Eye Recovery Pro (PH-e03)
- K261705 — Hair Removal Device (R3C16-G Pro, R3C16-V Pro)
Data sourced from openFDA. This site is unofficial and independent of the FDA.