FDA 510(k) clearances — page 131
clearances on record, most recent first.
Clearances — page 131
13,001–13,100 of 175,699- K220733 — OptiVu ROSA MxR
- K220901 — S-Core Implant System
- K220961 — Deep Learning Image Reconstruction
- K220989 — Next Generation NetKonnect
- K221242 — Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- K221251 — Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
- K221259 — Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System
- K221901 — EleGARD
- K221907 — RhinAer® Stylus (FG1393)
- K221914 — Catapult Guide Sheath
- K212113 — MagXtract Collection Tube
- K213998 — cvi42 Auto Imaging Software Application
- K214122 — BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
- K220063 — Single Use Cytology Brush
- K221230 — TRON
- K221235 — neXus Ultrasonic Surgical Aspirator System
- K221332 — OsteoCentric Spine MIS Pedicle Fastener System
- K221898 — Gastrointestinal Boundary Identifier (GIBI HD)
- K221905 — INERTIA CONNEXX Modular Pedicle Screw System
- K221922 — Trinias
- K221923 — Swoop Portable MR Imaging System
- K221945 — Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm
- K222014 — EXALT Model B Single-Use Bronchoscope
- K222017 — Biotres
- K210822 — DeepRhythmAI
- K210902 — EliA Ro52, EliA Ro60
- K211385 — KeriFlex® MCP and PIP Finger Joint Prostheses
- K211496 — TransLoc 3D
- K213252 — Dornier Thulio
- K213507 — AquaA
- K214007 — HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap
- K220876 — AOK 95A Medical Mask (20200049)
- K220886 — Upper Arm Type Blood Pressure Monitor
- K220922 — Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
- K220958 — Real Intelligence Cori
- K221254 — Hummingbird Tympanostomy Tube System
- K221269 — Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K221271 — Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
- K221430 — reVive Light Therapy LED Cleansing System
- K221464 — CorPath GRX System
- K221687 — Pegasus-X Expandable PLIF System
- K221853 — OTC DDR
- K221856 — BIOMONITOR IIIm, BIOMONITOR III
- DEN210032 — AccuMeasure System
- K212407 — Gastric Lightguide (GLG)
- K213858 — LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
- K214112 — Invia Ease Negative Pressure Wound Therapy (NPWT) System
- K221404 — Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
- K221502 — Parcus Synd-EZ SS
- K221567 — LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
- K221572 — VyPlate Anterior Cervical Plate System
- K221939 — Cemented Round Patella with JRNY Pegs
- K220439 — Viz SDH
- K220606 — Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2
- K220808 — Tigertriever 13 Revascularization Device
- K221409 — Paneffort 3-ply Surgical and Procedural Masks
- K221460 — BioFire COVID-19 Test 2
- K221877 — Powder-Free Nitrile Examination Glove, Non-Sterile
- K203680 — BioFire JI Control Panel M420
- K211346 — BLUE 400
- K211399 — Sterile Level 3 Surgical Gown
- K211891 — DM Converter - TiN coated
- K212975 — MedWand
- K213813 — DuraFuse Clip and Applier System
- K213922 — FX SPS
- K220064 — Synergy Marble (Model: Opasm)
- K220216 — C-Stem AMT LE Prosthesis
- K220486 — Kentrospine PSS Pedicle Screw System
- K220624 — AI4CMR v1.0
- K220882 — Vivid E80, Vivid E90, Vivid E95
- K220906 — SECURE-LOCK
- K220940 — EchoPAC Software Only, EchoPAC Plug-in
- K221196 — Disposable Medical Face Mask (ear loop)
- K221234 — TargetCool
- K221394 — 14HQ701G-B
- K221461 — 10HQ701G-B
- K221525 — PreXion3D Explorer PRO
- K221535 — Align Lumbar Interbody Fusion System
- K211543 — Wei Nasal Jet Tube
- K211952 — BTI Interna Narrow/Plus Dental Implant System UnicCa
- K213158 — Syringe with permanently attached needle
- K213773 — Insufflation Retention Device
- K213881 — Celerity Incubator
- K220184 — Pump Alignment Syringe
- K220671 — Manual Wheelchair
- K220976 — Life Scope PT BSM-1700 Series Bedside Monitor
- K221823 — Cionic Neural Sleeve NS-100
- K212178 — Root Apex Locator
- K213060 — AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle
- K214080 — Pentaflush
- K220039 — AutoSeg
- K220161 — Biofeedback Nerve and Muscle Stimulator
- K220679 — Pediatric Nailing Platform Femur
- K220956 — Libby Echo:Prio
- K221037 — TruDi Shaver Blade
- K221363 — AF Laser
- K221512 — Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)
- K221794 — Vario-Cup System
- K212215 — Tiche PTA Balloon Dilatation Catheter
- K213357 — Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
Data sourced from openFDA. This site is unofficial and independent of the FDA.