FDA 510(k) clearances — page 106
clearances on record, most recent first.
Clearances — page 106
10,501–10,600 of 175,620- K213825 — Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
- K220677 — Kurin Blood Culture Collection Set with Kurin Lock Technology
- K221390 — BNLE Access Guidewire
- K222004 — INTEGRATE -C Interbody Fusion System
- K222636 — ET Abutment System
- K222934 — Nanox.ARC
- K223634 — Customized Abutment
- K223677 — Titanium Abutment Blank Nobel Biocare N1 TCC
- K223862 — Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
- K230042 — Q-Rejuvalight Pro Facewear (Model: P19-0023)
- K230058 — Bladeless Trocar Artemis Lap Cannula
- K230480 — Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)
- K230597 — Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
- K230600 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
- K230908 — Hand Trauma Threaded Nail System
- K230972 — Ingenia Elition and MR 7700 MR Systems
- K213078 — Myolift QT
- K221963 — Cumulus Functional Neurophysiology Platform
- K221983 — Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color
- K222352 — Epildream HP 4000 MED
- K222381 — PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System
- K222694 — EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
- K223210 — ClotTriever XL Catheter
- K223212 — Precision DL
- K223398 — Gastric Alimetry System
- K223520 — UNIDRIVE SIII System
- K223734 — ENT EM
- K223892 — DentMix VPS Impression Material
- K230272 — Renuvion® APR Handpiece
- K230539 — ArtiSential Laparoscopic Instruments-Electrodes
- K230547 — PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter
- K230844 — Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert
- K230845 — 32HL512D, 31HN713D, 32HQ713D
- K230911 — Braun Skin i.expert
- K222548 — Endo Motor
- K222584 — EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100
- K222996 — Access PCT
- K223868 — PYXIS 3D Titanium Cage System
- K223932 — SafeAir combi (SFR-combi-US)
- K230499 — ArtiSential Laparoscopic Instruments-Electrodes
- K230552 — MR DWI/FLAIR Measurement V1.0
- K230553 — LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
- K230829 — TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
- K220513 — NITRO Interbody Fusion Cage System Family
- K222676 — Ceevra Reveal 3
- K223139 — Wallaby 017 Micro Catheter
- K230056 — MiVu Esophageal Endo Cap
- K230202 — TMINI Miniature Robotic System
- K230204 — ALPHALOK Plating System
- K230218 — DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
- K230223 — iCAC Device
- K230503 — Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable
- K230549 — IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG
- K230594 — Tigereye ST CTO-Crossing Catheter
- K230906 — Konicaminolta DI-X1
- K220261 — NEST-C Interbody System
- K220274 — Kisar Stratford SI Screw System
- K222330 — The Heart Seat
- K222690 — SmartGUIDE deflectable hydrophilic guidewire
- K223141 — STR8 Clear Aligner
- K223372 — Omnipod GO Insulin Delivery Device
- K230103 — Klockner Abutments
- K230136 — TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)
- K230140 — TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)
- K230704 — RAIN Sheath Tibial Pedal Introducer
- K221142 — Kyphoplasty Balloon System
- K221742 — CONNEQT PULSE
- K222210 — AEON Endoscopic Stapler
- K222291 — Paradigm System
- K222604 — dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S
- K223069 — Modular Rotating Hinge Knee Systems and Compatible Components
- K223300 — Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument
- K223501 — ViewFinder Software Version 1.1
- K230084 — HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
- K230468 — EzDent Web
- K230783 — Anatase Spine Surgery Navigation System
- K230789 — Knee+
- K230808 — PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
- K230811 — Digital Intraoral X-Ray Sensor
- K230816 — Intense Pulsed Light Treatment System
- K230819 — OmniGuide RFID Surgical Laser Fibers
- DEN220082 — Breast Implant Removal Device (BIRD)
- K211153 — Inomax DSIR
- K212220 — ArtFX Spinal Fixation System
- K220981 — SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
- K222095 — BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
- K222261 — Flexible Video-Choledochoscope System
- K223238 — STARband 3D
- K223287 — Velacur
- K223662 — Neodent Implant System - Helix Short Surgical Kit Cases
- K223768 — RadiForce RX270
- K230565 — HILINE Fixation System
- K230785 — Precision1, Precision1 for Astigmatism
- K230807 — Deep Learning Image Reconstruction
- K211748 — Selux AST System; Model AST Gen 1.0
- K220288 — NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector
- K221042 — Renova RP Centesis Pump
- K221220 — Montross Extremity Medical Hemi Implant System
- K223168 — Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface
- K223201 — TAP Lancet
Data sourced from openFDA. This site is unofficial and independent of the FDA.