FDA 510(k) clearances — page 91
clearances on record, most recent first.
Clearances — page 91
9,001–9,100 of 176,479- K231917 — VEA Align
- K232519 — ENDOCOLLECT Specimen Retrieval Bag
- K233229 — NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether
- K233316 — DESS Dental Smart Solutions
- K233679 — IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG)
- K221110 — LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing
- K223228 — Dayspring
- K230277 — Pulse Oximeter(Model OHT60,OXH78)
- K230507 — Zimed Distal Medial Tibial Plate and Screw System
- K230996 — Pursuant Health Kiosk (G1.D5)
- K231033 — CEPTRE® Knotted UHMWPE Suture PEEK Anchor
- K231058 — Hudson RCI® AddiPak® Unit Dose Vial
- K231072 — Anthogyr FlexiBase® titanium bases for Axiom® BL
- K232136 — syngo.CT Applications
- K232330 — Lancing System
- K232808 — Butterfly iQ3 Ultrasound System
- K233556 — LED Eye mask (EY-20R, A20, EY-20N)
- K233671 — Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance
- K223397 — HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens
- K231256 — Carecube Negative Pressure Isolation Chamber
- K231707 — ResQ Administration Set
- K231779 — REMI AI Discrete Detection Module
- K232589 — Horos MD
- K233395 — Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)
- K233550 — MOSAIC 3D (Surgical Laser)
- K223714 — UniFit Dental Implant System
- K230438 — URIS Smart Path Implant System & Prosthetic
- K230986 — Bladder Scanner
- K232688 — NQ TMS for MDD (NQv1-MU-01)
- K233362 — Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
- K233790 — ACL TOP 970 CL
- K233856 — Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal
- K230006 — Ankyras
- K230891 — SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant
- K230985 — Planmeca Viso
- K230997 — EvoWalk 1.0 System
- K231055 — x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)
- K233405 — Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim
- K231084 — TearCare MGX System
- K231914 — Nurochek-II System
- K232518 — EndoSound Vision System; EVS
- K232756 — Colibrí
- K233858 — TriSalus TriGuideTM Guiding Catheter
- K231130 — TumorSight Viz
- K232937 — BTL-899M
- K233300 — POWEReam 1/4 Drive
- K233515 — Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
- K233659 — Suture Wing
- DEN230020 — BioTraceIO Lite
- K223745 — Novae® Dual Mobility System, Hype® Hip System
- K230267 — NeuMoDx CT/NG Assay 2.0
- K230439 — WellCare Anoscope
- K231086 — CPM System
- K231794 — Elegant Advanced CompHort
- K231805 — qXR-LN
- K232293 — kallisio stentra oral stent
- K232300 — ElastiMed SACS
- K232338 — Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383
- K232479 — ART-Plan
- K232535 — MAGNETOM Sola; MAGNETOM Altea
- K232717 — Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
- K232789 — VIO System (V-1000)
- K232881 — Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder
- K233027 — NanoZoomer S360MD Slide scanner system
- K233058 — VivaChek Link Plus Blood Glucose Monitoring System
- K233082 — TopCEM Dual Cure Resin Cement
- K233104 — SofWave System
- K233109 — TP Pivot Pro Needle Guide
- K233205 — Distal Access Catheter
- K233264 — Anthogyr INTEGRAL Guided Surgery Cassettes
- K233304 — Omnimax S3, Omnimax S4
- K233734 — Interson USB Ultrasound System
- K233742 — CloudTMS Edge for OCD
- K234043 — 3M Transbond Orthodontic Adhesive
- K221753 — Kangbeier Child Surgical Mask
- K223359 — LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing
- K223729 — FLOWpresso
- K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
- K231027 — KaiBiLi Extended ViralTrans
- K231099 — SMR Hybrid Glenoid System
- K231307 — Elos Accurate Customized Abutment
- K231531 — Pediarity
- K231889 — Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)
- K232320 — iSR`obot Mona Lisa 2.0
- K232329 — Defendo Fujifilm 700 Single Use Biopsy Valve +4 more
- K232579 — Twoplus Applicator
- K232744 — syngo Virtual Cockpit (VB10A)
- K232784 — RELiZORB®
- K232870 — TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)
- K232888 — Disposable Laryngeal Electrodes
- K232944 — CALLISTO eye
- K233016 — Dental Glass Ceramics
- K233018 — PICOSECOND Nd:YAG Laser System
- K233112 — HM70 EVO Diagnostic Ultrasound System
- K233154 — SkyOPS Orthopedic Plate System
- K233276 — Reusable Blood Pressure Cuff
- K233396 — Cannulated Screw System
- K233423 — Tyber Medical Anatomical Plating System Line extension to the Mini-Frag System
- K233465 — RadiForce MX317W
- K233498 — Stryker Orthopaedics Hip Systems Labeling Update
Data sourced from openFDA. This site is unofficial and independent of the FDA.