FDA 510(k) clearances — page 234
clearances on record, most recent first.
Clearances — page 234
23,301–23,400 of 176,542- K191072 — 7410 Ultrasound System (MyLabSigma)
- K191310 — Insight Essentials DRF Digital Imaging System
- K190216 — SpaceFlex Knee
- DEN180057 — IB-Stim
- K180952 — Ceramic Bracket
- K182145 — tün® ultrasonic tips product family
- K182429 — Masimo O3 Regional Oximeter System
- K182519 — Miha Bodytec II
- K182573 — Hailie Sensor
- K183229 — Argen Clear Aligner
- K183311 — Ivenix Infusion System (IIS)
- K183632 — Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable
- K183649 — Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable
- K190051 — TD Clip
- K190057 — DJO Acetabular System
- K190388 — RIVAL View Plating Systems and Reduce Fracture Plating Systems
- K190503 — CeraSeal
- K190916 — VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20
- K191231 — Andorate Auxiliary Water Connector, Andorate Valves Set
- K191316 — VITROS XT Chemistry Products ALB-TP Slides
- K183620 — PROSTEP TBC Implant System
- K190568 — ComPAS2 (Computerized Pulmonary Analysis System)
- K190616 — VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)
- K190618 — RIGEL PEEK Anterior Cervical Interbody Fusion System
- K190827 — Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
- K191043 — da Vinci Handheld Camera
- K191220 — Pure Vu System
- K191263 — Idys ALIF TiVac
- K191335 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
- K180671 — MINE
- K183114 — Corin BiPolar-i
- K183559 — WatchPAT ONE
- K190505 — Low Dose Lung Screening Option
- K190576 — WalterLorenz Surgical Assist Arm Scope Holder
- K190585 — Biocode Gastrointestinal Pathogen Panel (GPP)
- K190595 — Signature ONE System
- K190804 — HydroCision TenJet Device
- K190874 — Materialise Mimics Enlight
- K191307 — Palm Bladder Scanner - PBSV5.1
- K183533 — Unity Total Knee System
- K183535 — Fully Automatic Electronic Blood Pressure Monitor
- K190068 — Vanguard XP Knee System
- K190245 — PDS Barbed Suture, PDO MAXX Threads
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.