FDA 510(k) clearances — page 225
clearances on record, most recent first.
Clearances — page 225
22,401–22,500 of 175,699- K183219 — Trio-CT Triple Lumen Catheter
- K183263 — UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
- K183431 — Medline Digital Rectal Thermometer Sheath
- K183566 — CLARITY II Laser System
- K190172 — Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
- K190414 — Moss Gastrostomy Tube, Moss Nasal Tube Mark IV
- K190700 — ELECTRODES PAD
- K191299 — Silhouette Featherlift / Silhouette Lift
- K191318 — AEQUALIS FLEX REVIVE Shoulder System
- K191387 — ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube
- K181514 — SeraQuest HSV Type 2 Specific IgG
- K181965 — Restore Toothpaste
- K182159 — Strome-Blitzer Cytology Balloon
- K182608 — Oyster ACIF Cage
- K183363 — Treace Medical Concepts (TMC) Snap-Off Screw System
- K183460 — ClariCT.AI
- K183513 — XenoSure Dura Biologic Patch
- K183564 — Electrosurgical Generator
- K190117 — Fiberoptix IAB
- K190133 — Full Automatic (NIBP) Blood Pressure Monitor-HL158UB
- K190228 — Transcranial Doppler Ultrasound System
- K190424 — HealthICH
- K190667 — Sonopet iQ Sterilization Tray
- K191005 — ProLift® Expandable System
- K191036 — SyMRI
- K191089 — Edwards Pressure Cable
- K191341 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
- K172232 — LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600
- K180511 — Eon FR
- K182749 — Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump
- K183046 — Aquilion ONE (TSX-305A/6) V8.9 with AiCE
- K183335 — Medline Poly-Cath Red Polymer Urethral Catheter
- K183691 — PENTAX Medical ENT Video Imaging System
- K183692 — Avid IF2
- K190016 — Lateral Plate System
- K190177 — J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,
- K190185 — Phasix ST Mesh with Open Positioning System
- K190422 — Viveve System 2.0
- K190521 — Aequalis Ascend Flex Shoulder System
- K191038 — On Call Express Voice Blood Glucose Monitoring System
- K191055 — HS40 Diagnostic Ultrasound System
- K191064 — Argon Handset
- K191115 — RS85 Diagnostic Ultrasound System
- K191291 — Wallace Dual Lumen Oocyte Recovery System
- K191331 — Life Sensor Cardiac Monitor
- K182416 — NOVA Minimally Invasive System
- K182656 — JAMBRO Single Core A Sterilization wrap
- K182713 — Scoreflex PTA Scoring Balloon Catheter
- K191226 — Arthrex SwiveLock Suture Anchor
- K191268 — Force Fiber Suture
- K191271 — T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System
- K191285 — Spine & Trauma Navigation
- K182650 — Arzzt Distal Radius and Ulna System
- K183104 — Mini Cannulated Headed and Headless Screw Set
- K183630 — SPINEART Navigation Instrument System
- K190220 — Vista FS, Vista FS Liquid
- K190814 — AccuFill Bone Substitute Material
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.