FDA 510(k) clearances — page 226
clearances on record, most recent first.
Clearances — page 226
22,501–22,600 of 175,699- K190461 — Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
- K190573 — KOWA DR-1a
- K190579 — TD-4183 Blood Glucose Monitoring System
- K190892 — MectaScrew PEEK Interference Screw
- K191340 — CORTRAK* 2 Equilateral Enteral Access System
- K182503 — Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
- K182625 — Diapex Plus
- K190337 — ReWalk Restore
- K191185 — Solanas® Posterior OCT Fixation System
- K190564 — Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB
- K190572 — Erchonia FX-635
- K182443 — Pristine Hemodialysis Catheter
- K182678 — Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling
- K182725 — Apis
- K190194 — C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
- K190240 — Tiger Sharps Containers
- K190246 — NeuroShield
- K190310 — U Deliver Bolink ENFit Enteral Feeding Sets
- K190543 — Cannulated Hemi Implant
- K190546 — NEXXT MATRIXX Stand Alone Cervical System
- K190565 — Cervical Plate
- K190757 — MAGNETOM Avanto Fit
- K190766 — PALACOS fast R+G
- K190831 — E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor
- K190896 — BriefCase
- K173158 — Air Relax
- K182308 — Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs
- K182611 — Qangio XA 3D
- K182660 — GaltTWS
- K183205 — PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
- K190160 — neXus Ultrasonic Surgical Aspirator System
- K190623 — Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device
- K190628 — FlexSeal Introducer Sheath with Hydrophilic Coating
- K191067 — Arc Endocuff Glide AEG110 & AEG120
- K191145 — MasterLoc Extension
- K191188 — ASHK100G
- K181630 — Revolution External Plating System
- K182403 — Peel-Away Introducer
- K182526 — Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)
- K182716 — Brain Perfusion (BP) application
- K182910 — Segmented Esophageal Stent System
- K183084 — Fuji Cervical Plate System
- K183336 — Entuit PEG, Entuit PEGJ
- K183337 — LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2
- K183645 — Silver High Performance Dressing
- K190167 — MitraClip G4 Steerable Guide Catheter
- K190510 — GuttaSil
- K190534 — Manual Wheelchair SIVFH2A102
- K190877 — Juliet® Ti LL Lumbar Interbody Device
- K190914 — MTS Doxycycline 0.016 - 256 µg/mL
- K191122 — 3M RelyX Pediatric Resin Modified Glass Ionomer Cement
- K191124 — Swiss LithoClast Trilogy
- K191157 — uMR 780, uMR 790
- K180739 — Clearlink System Solution Set
- K182544 — AccelFix Spinal Fixation System
- K190468 — Nihon Kohden SVM-7200 Series Vital Signs Monitor
- K190474 — MectaLock PEEK Suture Anchor
- K190482 — IGNITE Bone Void Filler
- K190606 — Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
- K190686 — Optilite IgM CSF Kit
- K182515 — Surgical Face Mask
- K181157 — Conical Plus Implant System
- K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
- K182321 — MobileLink Acetabular Cup System
- K182575 — Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
- K183530 — TruDiagnosis System
- K190077 — Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove
- K190231 — InCore® Lapidus Sterile Kits
- K190282 — Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
- K190378 — Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix
- K190448 — LightLas Pattern Scanning System - TruScan Pro
- K190542 — Soliton Acoustic Wave Device
- K190603 — Tria Firm Ureteral Stent
- K190802 — Envision ultrasound pad and cover
- K191083 — COMPLETE CONTROL System Gen2
- DEN180032 — Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit
- DEN180069 — ZIKV Detect 2.0 IgM Capture ELISA
- K182362 — MaxCap Ped and MaxCap Neo
- K182390 — IMPEDE-FX Embolization Plug
- K182458 — Longterm NPWT Foam Dressing Kit
- K182937 — Upstream GoBack Crossing Catheter
- K183054 — SYNMESH System
- K183560 — Luna 3D GEN2 Interbody Fusion System
- K183639 — Mariner Outrigger Revision System
- K183654 — PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus
- K190018 — Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
- K190436 — KATANA Zirconia Block
- K190441 — Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit
- K190452 — Aptima BV Assay
- K190469 — ERBEFLO 2 Disposable Tubing System
- K190515 — Aptima Combo 2 Assay (Panther System)
- K191091 — Rampart One Lumbar Interbody Fusion System
- K182350 — Dental Ceramic
- K182374 — LIAC S
- K183611 — Soniquence RF Generator and Soniquence Electrodes
- K183644 — Stealth-Midas MR8 System
- K190433 — cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit
- K190444 — HERA I10 Diagnostic Ultrasound System
- K190751 — Connector System
- K190769 — Bladder Scanner (Models: M2, M2-W, M1, M1-W)
Data sourced from openFDA. This site is unofficial and independent of the FDA.