FDA 510(k) clearances — page 220
clearances on record, most recent first.
Clearances — page 220
21,901–22,000 of 175,699- K191626 — Stat Profile Prime ES Comp Plus Analyzer System
- K191636 — APTUS Foot System
- K191645 — SKR 4000
- K191899 — Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
- K191924 — SAFECARE® THC Urine Strip Test
- K191933 — COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal
- K192018 — Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device
- K183208 — Suprasorb A + Ag R
- K183230 — OneDraw A1C Test System
- K183282 — Biovitals Analytics Engine
- K190264 — Viola
- K190328 — HCT Empty EVA Container Pack
- K190610 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
- K190925 — HeartFlow FFRct Analysis
- K190991 — Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment
- K191200 — TULSA-PRO System
- K191621 — ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System
- K191916 — Stryker CMF MEDPOR Priority Customized Implant Kit
- K191922 — ACUSON P200 Diagnostic Ultrasound System
- K182618 — SleepImage System
- K190063 — Servator C SALF Solution
- K190261 — BOSS Toe Fixation System
- K190689 — SignalMark Breast Marker
- K190849 — IS-III active System_S-narrow Type
- K190852 — Zurich Pressure Guidewire System Model 100
- K191241 — AutoStrut
- K191553 — NuVaisve® Reline® Cervical System
- K190428 — Elecsys Anti-HAV II
- K190970 — PROSTEP TBI (Tailors Bunion Implant) System
- K191024 — xPORT Lens Fragmentation System
- K191376 — Modular Power Standing System
- K191582 — Cartesion Prime
- K191731 — Instylla Microcatheter
- K183182 — Critical Care Suite
- K183316 — Dr J Spinal and Epidural Needles
- K190025 — EVOL® -SI Joint Fusion System
- K190491 — Blue Sky Bio Zygomatic Implant System
- K190870 — Cervical Spinal Truss System-Stand Alone (CSTS-SA)
- K191009 — Arsenal Plating System
- K191311 — ATEC Lateral Interbody System
- K191494 — Facilis Spinal System
- K182881 — Bone Screw, Bone Tack
- K183158 — NxStage Cartridge Express with Speedswap
- K183203 — ELAN 4 Tools
- K183647 — SOLTIVE Laser System(SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVELaser Fibers, and Accessories)
- K190371 — Morpheus-C
- K191114 — Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle
- K191233 — ARIETTA 750
- K191560 — Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter
- K191792 — Versana Balance
- K191798 — Versana Active
- K191884 — DR 100s
- K181760 — Transit-Pellets
- K183312 — Conformity Stem
- K190385 — CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System
- K190562 — iTotal Identity Cruciate Retaining Knee Replacement System
- K190674 — REFRESH RELIEVA For CONTACTS
- K190716 — Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead
- K191257 — Erchonia EVRL
- K191352 — binx health io CT/NG Assay
- K191575 — ARx Spinal System
- K183276 — 7D Surgical System
- K190650 — Revolution Centrifugal Blood Pump
- K190885 — Elevation Spine Saber-C System
- K190893 — Non-invasive Hemodynamic Blood Pressure Monitor
- K191012 — Navigated Pedicle Access Kit
- K191274 — BonAlive Granules
- K191394 — ILLUMISITE Platform
- K191606 — RenovoCath
- K191840 — Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
- K191841 — Accurate Multi Panel Drug Urine Test Cup
- K191871 — 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
- K183120 — EmboCube Embolization Gelatin
- K183387 — M3290B Patient Information Center iX
- K183458 — exoplan 2.3
- K190502 — ENFit Oral / Enteral Syringe
- K190535 — BiMobile Dual Mobility System - E-Dur Inserts
- K190992 — OrthoPediatrics PediFoot Deformity Corrections System
- K191158 — The AIO Solution
- K191295 — Percutaneous Introducer Needle
- K191423 — Normandy VBR System
- K191565 — Endoskeleton TCS Interbody Fusion Device
- K191781 — Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System
- K191835 — CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments
- K183305 — Crossing Support Catheter
- K183323 — UPJ Occlusion Balloon Catheter
- K190399 — Beddr 200 System
- K191033 — LunaGuard Nighttime Dental Protector
- K191222 — Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV
- K191225 — EEG Electrode Template
- K191262 — aBSI
- K191496 — TDS Standard Solution
- K191766 — VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
- K191877 — FLUOROspeed
- K181154 — Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor
- K181216 — HAMILTON-T1, HAMILTON-C1
- K183088 — ADVIA Centaur Erythropoietin (EPO) assay
- K183091 — Elaris Pedicle Screw System
- K183112 — DiLumen Endolumenal Interventional Knife (DiLumen IK)
- K190090 — DynoSense Vital Sign Measuring System
Data sourced from openFDA. This site is unofficial and independent of the FDA.