FDA 510(k) clearances — page 206
clearances on record, most recent first.
Clearances — page 206
20,501–20,600 of 175,699- K192127 — Respire Pink AT (Hard, Hard/Soft, EF)
- K192785 — OptiScanner® 5000 Glucose Monitoring System
- K192806 — DENTCA Crown and Bridge
- K193396 — PERLA® TL posterior osteosynthesis system
- K200038 — Endosee System
- K200170 — SpineNet SSP System
- K183148 — OKLand Patient Return Electrode Pad
- K191532 — The Caterpillar and Caterpillar Micro Arterial Embolization Devices
- K191832 — Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)
- K192688 — s-Clean SQ-SL Implant System Regular
- K193320 — KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
- K193324 — Motion Correction System
- K193398 — Summit DuoFix HA Coating
- K200050 — Akesis Galaxy RTx
- K190842 — Comus Locking Plate systems
- K190962 — Bella-mu
- K190966 — Katalyst Training System
- K192579 — X-Guide Surgical Navigation System
- K193128 — Mako Total Hip Application
- K200030 — Optima Coil System
- K191330 — Arc Enterocuff
- K191539 — 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support
- K192163 — TTC Phantom® Intramedullary Nail System
- K192234 — ActiPatch
- K192462 — syngo.MR Applications
- K192535 — Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia
- K193192 — Tamper Evident Cap
- K193257 — ACUSON Sequoia Diagnostic Ultrasound System
- K193258 — ProLift Expandable System
- K193270 — CapLOX II®/TowerLOX® MIS Pedicle Screw System
- K193284 — Physica LMC Knee System
- K193480 — BIOEASY Multi-Drug Test Cup
- K200018 — HAD1717MC
- K190734 — Linshom Respiratory Monitoring Device (LRMD)
- K190956 — SCS 17-01
- K191254 — EndoClot
- K192339 — TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
- K192397 — TruDi Navigation System
- K192889 — Neo
- K192941 — HySil Super Fast Impression Materials
- K193057 — ATTUNE All-Polyethylene Tibia
- K193060 — Noritake Super Porcelain EX-3
- K193339 — GTK Veress Needles
- K183106 — TruAbutment DS
- K191323 — Carescape B850
- K191380 — Quantum® Total Ankle Prosthesis
- K191472 — Biopsy Needle
- K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
- K191677 — MectaTap TI Suture Anchor
- K191837 — UniSmile Clear Aligner System
- K191926 — VITA VIONIC Bond
- K191937 — Ezvena IPC, Ezvena SQS
- K191989 — WVSM (Wireless Vital Signs Monitor) RWC + miniCap
- K192585 — Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap
- K193051 — LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
- K193099 — Anatomical Shoulder System
- K193642 — Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
- K192146 — V-DENUPET
- K192581 — The NightBlocks Appliance
- K193510 — Terason uSmart3200T Ultrasound System
- K193637 — MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System
- K191715 — Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile
- K192090 — CMOS Video Rhino-Laryngoscope SSU
- K193315 — Xenocor Articulating Xenoscope Laparoscope
- K193365 — M.U.S.T. Pedicle Screw System
- K193241 — Emission Computed Tomography System
- K193512 — THD Procto Software System
- K191186 — Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode
- K191144 — Cellvizio 100 Series System with Confocal Miniprobes
- K191227 — Paratrooper Plantar Plate Repair System
- K191249 — CARESCAPE B450
- K191293 — LCCS VC-S RF Cannula
- K191406 — KardiaMobile, KardiaStation
- K191432 — cortiQ PRO
- K192014 — SYPMHONY OCT System
- K192333 — Blue Nitrile Examination Gloves Powder Free
- K192493 — BD Cathena (TM) Safety IV Catheter
- K192523 — CMOS Video Esophagoscope SSU
- K192608 — Disposable SpO2 Sensor
- K192641 — Gemini Titan Sterilization Wrap
- K192859 — CareSens S Clear BT Blood Glucose Monitoring System
- K192984 — APTUS Clavicle System
- K193109 — MRCAT brain
- K193223 — Persona Personalized Knee System
- K193246 — Stat Profile Prime Plus Analyzer System
- K193261 — FlightPlan for Embolization
- K193263 — Reprocessed Achieve Catheter Connecting Cable
- K193454 — IQon Spectral CT
- K190120 — VINNO 8, VINNO 6, VINNO 5
- K190271 — FiteBac Cavity Cleanser
- K190839 — GammaTile
- K191014 — Elements Viewer
- K191270 — Proneb Max
- K191821 — Blue Phantom PT
- K192025 — STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader
- K192092 — Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535
- K192170 — VistaScan USB Ultrasound Imaging System
- K192330 — EEA Circular Stapler with Tri-Staple Technology
- K192349 — Bactisure Wound Lavage
- K192436 — Healing Abutments and Cover Screws
Data sourced from openFDA. This site is unofficial and independent of the FDA.