FDA 510(k) clearances — page 216
clearances on record, most recent first.
Clearances — page 216
21,501–21,600 of 176,479- K191642 — TK Sterile Piston Syringe without Needle
- K192412 — SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece
- K192497 — EVOL ha - D Lateral Interbody Fusion System
- K192827 — Quadra-P
- K192903 — RS85 Diagnostic Ultrasound System
- K192917 — ViewPoint 6
- K193102 — MRIaudio PREM System with MRIview
- K193125 — R2P Destination Slender Guiding Sheath
- K192696 — TriMed ASET Foot Plating System
- K181546 — Dillard Nasal Balloon Catheter
- K190243 — Z5-BL
- K190669 — Endotics
- K191056 — Conformity stem, cemented
- K191195 — PiccGuard
- K191501 — PALLAS 308/311 Solid-State UV Laser System
- K192893 — Straumann Ceramic Healing Abutments
- K193140 — Flex Body SPEEDER
- K193239 — MPowRx Snoring Solution (also known as Good Morning Snore Solution)
- K193359 — SureMAX Family of Cervical Spacers
- K193375 — NeuroBlate System
- K193431 — AlignRT Plus
- K183089 — Air Next
- K191061 — Optilume Basic Urological Balloon Dilation Catheter
- K191147 — OC-Auto SENSOR io iFOB Test
- K191446 — Ureteral Stent Systems, Biliary Drainage Catheters
- K191739 — Sterile LeadConfirm
- K191907 — OptoWire III
- K192216 — Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP
- K192457 — Elos Accurate Customized Abutment
- K192599 — ASAHI PTCA Guide Wire ASAHI Gaia Next
- K193092 — TunneLoc Tibial Fixation Device
- K193360 — Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard
- K190990 — Digital Thermometer
- K192343 — Patient Monitor
- K192444 — mCare® Powder Free Nitrile Black Examination Glove
- K192578 — InCore TMT System
- K192912 — AutoMIStar
- K193381 — RadCalc Software
- K190241 — Sterile Latex Surgical Glove, Powder Free
- K192258 — Disposable Valve Sets
- K192655 — Depuy Synthes Maxillofacial Portfolio - MR Conditional
- K191059 — Masimo Rad-97 and Accessories
- K191256 — Straumann BLX Ø3.5 mm Implants
- K191696 — Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
- K192196 — Medical Radiation Dosimetry System microSTARii
- K192695 — InMode System with the Morpheus8 (Fractora) Applicators
- K192700 — Xcam
- K192939 — Volumetric Specimen Imager
- K193149 — True 3D Viewer Software
- K193403 — UroNav System
- K190467 — iHelmet Hair Growth System
- K190884 — TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
- K192768 — Temporary Fixation Pins
- K193050 — Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem
- K192135 — VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)
- DEN180067 — Mucosal Integrity Conductivity (MI) Test System
- K182718 — Mini and Micro Fragments Reconstruction System GMReis
- K190665 — Neodent Instrument Kit Cases
- K190736 — Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs
- K190860 — Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color
- K191551 — RIST Cath Radial Access Long Sheath
- K191846 — MAXReach Laser Probe
- K191960 — Arthrex Univers Revers Modular Glenoid System
- K192023 — Arm Blood Pressure Monitor
- K192104 — Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs)
- K192485 — BioCode Respiratory Pathogen Panel (RPP)
- K192487 — EZ-TRAX Containment Device
- K192645 — Trigon Ti Stand-Alone Wedge Fixation System
- K192733 — RelieforMe TENS/EMS Device Model UPK-GE01
- K193254 — 3M Attest Steam Chemical Integrator
- K193279 — Comet II Pressure Guidewire
- K192559 — Acetabular Bone Screws (for MobileLink Acetabular Cup System)
- K192629 — Spinalytics
- K183213 — IceSense 3, ProSense, MultiSense
- K190008 — Carescape One
- K190112 — Non-Sterile Zirconia Block
- K190284 — Bengal Stackable Cage System
- K190633 — NanoOrtho NanoKnee® System
- K190730 — IODOSORB
- K190756 — IODOFLEX
- K190805 — PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL
- K190929 — xvision Spine system (XVS)
- K191234 — APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets
- K191350 — ACTIVE® Free Testosterone RIA
- K191403 — Pulse Oximeter
- K191440 — Paragonix SherpaPak Pancreas Transport System
- K191647 — QLAB Advanced Quantification Software
- K191666 — Unscented W long plastic and cardboard applicator tampons
- K191823 — Clear-Aligners
- K191836 — Ceramill A-Splint
- K191879 — DRX-Evolution with Carestream Digital Tomosynthesis
- K191967 — Unyvero LRT BAL Application
- K192027 — WEREWOLF COBLATION System, COBLATION HALO Wand
- K192040 — AVIEW Modeler
- K192178 — R&D Series Nova Compo N
- K192383 — BriefCase
- K192470 — DenMat Orthodontic Aligners
- K192471 — RHIN1 Stylus
- K192711 — Dannik Titanium Ligation Clip
- K192718 — Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology
Data sourced from openFDA. This site is unofficial and independent of the FDA.