FDA 510(k) clearances — page 2
clearances on record, most recent first.
Clearances — page 2
101–200 of 176,013- 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)
- K262427 — Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)
- K251544 — Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)
- K252571 — mdprostate
- K253453 — Metrix COVID Test; Metrix COVID Test Pro
- K253505 — Zamenix P
- K253554 — Aperio GT 450 DX; Aperio GT 180 DX
- K253561 — Aperio iQC DX Software
- K253702 — Intuitive Endoluminal Gastrointestinal System (IG1000)
- K254205 — Zenition 30
- K260567 — EW10-EC02 Endoscopy Support Program
- K260933 — Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)
- K261028 — Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
- K261362 — Xpert Hemorrhagic Fever
- K261437 — Mistral-Air® Warming System
- K261563 — Freedom Total Knee System (E-Poly Tibial Liners)
Data sourced from openFDA. This site is unofficial and independent of the FDA.