FDA 510(k) clearances — page 214
clearances on record, most recent first.
Clearances — page 214
21,301–21,400 of 176,479- 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
- K192530 — Surefil one Self-adhesive Composite Hybrid
- K193295 — Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor
- K193504 — HardyDisk AST Cefiderocol 30ug (FDC30)
- K190837 — Internal Hex Implant System
- K190954 — Fundus Camera
- K191093 — Isopure Dry Acid Dissolution System
- K191109 — Spectra Q
- K191322 — E-EEGX, N-EEGX
- K192161 — FastFit EMS System
- K192502 — Anatomic PEEK Cervical Fusion System, Anatomic PEEK PTC Cervical Fusion System, Capstone Spinal System, Capstone PTC Spinal System, Capstone Control Spinal System, Capstone Control PTC Spinal System, Clydesdale Spinal System, Clydesdale PTC Spinal System, Cornerstone PSR Cervical Fusion System, Crescent Spinal System, Crescent Spinal System Titanium, Divergence Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L Anterior/Oblique Lumbar Fus
- K192684 — HydroPearl Microspheres
- K192993 — SCARLET AL-T
- K193574 — Q-Rad System
- K193606 — Y-Knot OneStep Anchor
- K191149 — CARESCAPE B650
- K191229 — TrapIt
- K191425 — Hydro-Temp Neonatal Skin Temperature Probe Cover
- K192564 — Disposable Gold Cup EEG Electrodes
- K192985 — Medline Glide-On 3G Vinyl Examination Gloves
- K193370 — Nexxt Matrixx System
Data sourced from openFDA. This site is unofficial and independent of the FDA.