FDA 510(k) clearances — page 341
clearances on record, most recent first.
Clearances — page 341
34,001–34,100 of 176,542- K151469 — CORVUS Radiation Therapy Planning System
- K151656 — HEARTWAY Power Mobility Scooter
- K152000 — SMV Scientific Bone Plate and Screw System
- K152490 — DERMABOND PRINEO Skin Closure System
- K152494 — Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments
- K152573 — 4Sight
- K152761 — Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G)
- K152779 — Avex CX2
- K152785 — XIDF-AWS801, Angio Workstation, V6.20
- K152822 — VidiStar HeartView
- K152939 — Picasso Plus, Picasso Lite Plus
- K153096 — LARIAT RS Suture Delivery Device
- K153142 — Carestream DRX-1 System with DRX Plus 4343 Detectors
- K153180 — Tyber Medical MST Trauma Screw
- K153182 — SELF- COMPRESSIVE SCREW
- K133178 — LUXATOR LX HANDPIECE
- K142955 — SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power
- K150550 — SilverCoat Silicone Foley Catheter
- K150618 — PENTAX Medical EPK-i7010 Video Processor with GI Family
- K151125 — AVAflex Vertebral Balloon System
- K151191 — OES ELITE Telescopes, Protective Tube
- K151265 — SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System
- K151378 — Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
- K152046 — Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)
- K152057 — OsteoCool V-3 RF Ablation System
- K152225 — Edwards eSheath Introducer Set
- K152242 — G3¿ Active Plate® Large Fragment System
- K152838 — HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50
- K152841 — Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
- K152846 — HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40
- K153150 — AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000
- K143669 — MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter
- K143704 — Advanced Air System
- K151739 — Revision Femoral Stem
- K151764 — YAMAHACHI PMMA DISKS
- K152055 — Ceramax Skin Barrier Cream
- K152067 — Ponto bone anchored hearing system
- K152272 — Arrow Endurance Extended Dwell Peripheral Catheter System
- K152349 — Star+ VPS Scannable Impression Material
- K152495 — Wondfo Propoxyphene Urine Test
- K152762 — Fogarty Occlusion Catheter
- K153102 — QuadraSphere Microspheres
- K153115 — Arthrex Univers Apex, Size 5 Stem
- K151034 — PainKARE
- DEN150001 — RELIZORB
- K142617 — ArcCHECK
- K150514 — Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters
- K150525 — SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
- K150571 — 3i T3 Short Implants
- K150698 — Gemini Sterilization Wrap
- K150825 — Collagen Dural Regeneration Matrix
- K151414 — IQQA Guide
- K151692 — BioArchitects Patient Specific Cranial/Craniofacial Plate
- K151738 — Single Use Aspiration Needle NA-U200H
- K151770 — Libra Pedicle Screw System
- K151773 — CONCORDE Bullet Lumbar Interbody System
- K151792 — Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System
- K152110 — e-1 etchants
- K152282 — Cam Lock Plating System
- K152434 — XprESS Multi-Sinus Dilation System
- K152435 — PassAssist LED Light Fiber
- K152641 — Pi Drive Plus Motor, Extender
- K152711 — Parcus GFS Naked
- K152713 — 8MP Color LCD Monitor, RadiForce RX850, RX850-AR
- K152853 — WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
- K153086 — RX ACCUNET Embolic Protection System
- K153219 — ProFlu+ Assay
- K143310 — MoisturemeterD
- K150094 — Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla
- K150299 — Gmate SMART Blood Glucose Monitoring System
- K150455 — RT2 Trabeculite Titanium Cervical Cage System
- K150637 — Aerin Medical Wand Model FG011
- K150645 — AN1087 Dosimeter
- K150799 — Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula
- K150985 — Medihoney Wound Gel
- K151296 — Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
- K151344 — Cytoflex Tefguard Ti-Enforced Membrane
- K151710 — SNaP Wound Care System
- K151791 — Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir
- K151816 — TLC-2000 Therapeutic Medical Laser System
- K152259 — InFill Interbody Fusion Device
- K152304 — Tritanium PL Cage
- K152829 — Visions PV.014P RX Digital IVUS Catheter
- K153101 — BladderScan Prime System
- K143630 — Invisalign System
- K150644 — AN85/AN86 EO Indicators
- K150646 — EOGas 4 Ethylene Oxide Gas Sterilizer
- K150684 — WASTON General Spinal System
- K151234 — R350 guidewire
- K151585 — Andersen EOGas 4 SteriTest
- K152058 — Tyvek Sterilization Pouches with Chevron Seal
- K152514 — Clickfine AutoProtect Pen Needle
- K152695 — 8 CH Knee SPEEDER
- K152758 — Venue 50
- K153022 — Philips IntelliSpace Cardiovascular
- K151004 — PULLUP® Adjustable Juxtacortical Fixation Device
- K151682 — Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
- K152004 — Nanova Universal Composite
- K152041 — Renaissance X System
- K152318 — MD-2300S Ultrasonic A/B Scanner for Ophthalmology
Data sourced from openFDA. This site is unofficial and independent of the FDA.