FDA 510(k) clearances — page 107
clearances on record, most recent first.
Clearances — page 107
10,601–10,700 of 176,479- K223322 — Argus Cognitive ReVISION Software
- K223347 — UltraSight AI Guidance
- K223752 — Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl
- K230333 — Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
- K231523 — EsCom250
- K230931 — Atlan
- K211218 — BD Alaris System with Guardrails Suite MX v12.1.2
- K221319 — BD Alaris Pump Epidural Infusion Set
- K221327 — BD Alaris Pump Infusion Sets
- K223037 — Infrared Thermometer, Model: IR8807
- K223189 — Firefighter NC Pro PTCA Balloon Catheter
- K223288 — Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
- K223316 — Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System
- K223317 — Alkaline Phosphatase2
- K223499 — Three Way Stop Cock
- K223637 — Elecsys proBNP II, Elecsys proBNP II STAT
- K223769 — NextAR Spine Platform
- K230150 — OptimMRI
- K230560 — enspire 300 Series Automated Endoscope Reprocessor System
- K231021 — KIMTECH Polaris Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
- K231161 — 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe
- K231173 — Irregular Rhythm Notification Feature (IRNF)
- K231474 — Erchonia Violet ZERONA® Z6 OTC
- K231483 — MySpine Unilateral Guides
- K231516 — INHANCE Shoulder System, Sterile Single Use Instrumentation
- K231848 — Triever20 Curve (21-201)
- K231861 — EndoflipTM 300 System
- K231862 — TruDi® Navigation System V3 (FG-2000-00)
- K213098 — Panther 5
- K220977 — ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
- K222920 — Oxygen concentrator
- K223301 — ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System
- K223484 — IGAR System (1001.A)
- K223834 — AccuCheck
- K230039 — uOmnispace
- K230377 — CROSSLEAD Penetration Peripheral Guide Wire
- K230787 — Oscar 15 & Oscar 15i
- K230875 — Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
- K231103 — ROSA ONE Brain Application
- K231790 — The InMode System with the Morpheus8 Applicators
- K231799 — INERTIA® CONNEXX Modular Pedicle Screw System
- K231808 — QUASAR Standalone ACIF System
- K231840 — CastleLoc-S Posterior Cervical Fixation System
- K231945 — VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits
- DEN220047 — Galen ES Cooperative Surgical Assistant Platform, Galen ES
- K210801 — AXINON® LDL-p Test System
- K223151 — Nu-beca Transcutaneous Electrical Nerve Stimulation
- K230037 — BACK 3
- K231157 — syngo.CT Lung CAD (Version VD30)
- K231292 — TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System
- K231410 — RenaPure Endotoxin Retentive Filter
- K231437 — LF900
- K231448 — TANDEM Hip System
- K231472 — Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)
- K231796 — Grreen X 12 (Model: PHT-75CHS)
- K231839 — CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System
- K213100 — FMT Reusable Temperature Probes
- K221107 — TRUST
- K222925 — Hypodermic Syringes & Needle
- K223339 — Bone Chamber Implant
- K230716 — Robotic Graft Delivery Instruments
- K230945 — Forma Medical Headless Compression Screw
- K211143 — Pulse Oximeter
- K213953 — BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes
- K222683 — Fibroid Mapping Reviewer Application (FMRA)
- K223252 — TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas
- K230077 — LaserME
- K230087 — POINT Kinguide Agile Hybrid Navigation System
- K230257 — Arthrex Intramedullary Nails
- K230395 — Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
- K230407 — FloNavi Open Field Fluorescence Imaging System
- K230462 — OPTIX H2 Patient Specific Instrument System
- K230558 — Revital-Ox PAA High Level Disinfectant Chemical Indicator
- K230846 — iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System
- K231441 — ARIX Ankle System
- K231456 — Avitus® DragonWing Large Volume Autograft Delivery System
- K231460 — FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM & BALTEUM-ONE Lumbar Plate System, and Osprey Anterior Cervical Plate System
- DEN230012 — Ruthless Spine RJB
- K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System
- K221673 — Bonafix TiBase
- K222026 — Neodent Implant System - Zirconia Implant System
- K223106 — Brainlab Elements Image Fusion, Contouring (4.5) +4 more
- K223173 — Proxeo ULTRA (PB-510, PB-520 and PB-530)
- K223290 — CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)
- K223791 — TalWire
- K223886 — Wearable Breast Pump (Model S18)
- K230016 — Cercare Medical Neurosuite
- K230269 — Ultraflex Tracheobronchial Stent System
- K230445 — OnX Tough
- K231041 — JiveX (Model Number / Release: 5.4)
- K231392 — NaviNetics Reusable Stereotactic System (NN1000)
- K231428 — Mobility Scooter (Models: W3431D)
- K231757 — Ez3D-i /E3
- K231782 — FlowSaver Blood Return System (80-101)
- K231841 — PathLoc SI Joint Fusion System
- K221961 — HydroMARK Plus Breast Biopsy Site Marker
- K222116 — Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
- K223125 — XR90 (XR90-SYS)
- K223261 — Open Rib
- K223424 — Spine Auto Views
Data sourced from openFDA. This site is unofficial and independent of the FDA.