FDA 510(k) clearances — page 230
clearances on record, most recent first.
Clearances — page 230
22,901–23,000 of 176,542- K191398 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System
- K191535 — CoLink® Mini Plating System
- K191797 — BiomarC Fiducial Marker
- K190996 — Bonus Therapeutics Mixing and Delivery System
- K182384 — ACR LAB Urine Analysis Test System
- K182889 — KLS Martin Individual Patient Solutions (IPS) Planning System
- K183129 — Medtronic Total Hip Arthroplasty System
- K183194 — Arthrex Eclipse Shoulder Prosthesis System
- K183271 — AI-Rad Companion (Pulmonary)
- K183280 — PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs
- K183486 — RapidVit Oocyte, RapidWarm Oocyte
- K190062 — STATCLAVE G4 Chamber Autoclave
- K190533 — Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented
- K190685 — Hair Growth System
- K190873 — Infrared Ear/Forehead Thermometer
- K190949 — ScanX Barrier Envelopes
- K191328 — Megadyne Foot Switch
- K191396 — Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
- K191714 — ASAHI Neurovascular Guide Wire CHIKAI X 014 soft
- K191733 — The ZIP Accessory Shuttle for PleuraFlow System
- K191736 — da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30
- K191777 — Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
- K191817 — ActivOrtho Continuous Compression Screw System
- K180845 — Maxima Electric System
- K182659 — Galilei G6 Lens Professional
- K183017 — Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer
- K183066 — The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model
- K183249 — Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage
- K190292 — Passio Pump Drainage System
- K190774 — RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant
- K190819 — Silicone PHMB Foam Wound Dressing
- K190910 — PrisMax System Version 2
- K191173 — Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires
- K191211 — JOURNEY II Unicompartmental Knee System
- K191789 — Stonetome Stone Removal Device
- K182942 — Canon OCT-A1
- K182984 — MaxiTears Contacts PF
- K190471 — 4CIS® Chiron Spinal Fixation System
- K190587 — Coolrail Linear Pen
- K190678 — TempSure
- K191100 — ExcelsiusGPS Spine 1.1 Interbody Module
- K191699 — Discovery XR656 HD with VolumeRad
- K191729 — Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
- K190488 — ProLift Expandable System
- K190926 — Hammertoe Truss System (HTS)
- K190963 — DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional
- K191662 — Vantage Orian 1.5T, MRT-1550, V4.5
- K182817 — CottonDay Tampon
- K182985 — Roadrunner PC Wire Guide, Olcott Torque Device
- K190834 — Corin Optimized Position System Functional Hip Analysis (OPS FHA)
- K190975 — Plexus SCD110 Sequential Compression Device Sleeve
- K191078 — BAROnova Access Sheath Kit
- K191092 — Powder-Free Vinyl Patient Examination Gloves, Yellow Color
- K191374 — Revival Modular Hip Stem
- K191593 — Digital Automatic Blood Pressure Monitor MD36 Series
- K182487 — CerusEndo Microcatheter
- K191660 — CARTO 3 EP Navigation System, Version 7.1 and Accessories
- K182407 — Exceed Microneedling device
- K182798 — KIDScore D3
- K182940 — Surdial DX Hemodialysis System
- K182971 — SpaceOAR Vue Hydrogel
- K183349 — AeroDVx System
- K183545 — Anspach Helix Dissection Tools
- K190050 — Tech Dots - Adhesive and conductive gel
- K190260 — STERIZONE(R) VP4 Sterilizer
- K191117 — NvisionVLE Low-profile Optical Probe
- K191309 — syngo.via MI Workflows VB40A, Scenium
- K191365 — Stat Profile Prime ES Comp Plus Analyzer System
- K191467 — Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0
- K191633 — Infyna Chic
- K191648 — Mariner MIS Pedicle Screw System; SeaSpine Navigation System
- K191757 — EUROPA Pedicle Screw System
- K181166 — Trilogy Evo
- K181170 — Trilogy Evo Universal
- K182794 — BionicGym Powered Muscle Stimulator
- K182908 — Ziacom Dental Implant Systems
- K183121 — Qraypen
- K183532 — Latitud Hip Replacement System
- K190343 — Silverlon Wound Contact, Burn Contact Dressings
- K190427 — Immucise
- K190492 — Peralta Stone Removal Catheter
- K190680 — FAVO S-TLIF
- K190895 — MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System
- K191048 — AcuSnare Polypectomy Snare - Duckbill
- K191060 — ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit
- K191140 — MONTAGE-QS Settable, Resorbable Hemostatic Bone
- K191370 — DreaMed Advisor Pro
- K191598 — AOS ES Retrograde Femoral Nail
- K191615 — Huvitz Imaging System
- K191755 — SPAR-K Instruments (for use with Gemini SL Total Knee System)
- K182820 — The POD
- K183270 — Silent Nite sl
- K191053 — Xtreme-Loop
- K191068 — Powersculp laser lipolysis system
- K191167 — Fungitell STAT
- K191345 — Pegasus System
- K191578 — ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
- K191711 — ORTHOLOC SPS Shoulder Plating System
- K180992 — Biotex
- K183051 — Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
Data sourced from openFDA. This site is unofficial and independent of the FDA.