FDA 510(k) clearances — page 5
clearances on record, most recent first.
Clearances — page 5
401–500 of 176,428- K261811 — PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2 +1 more
- K262269 — CO2 Laser System (MBT- CO2 Laser)
- K262451 — Arthrex DynaNite Staples
- K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
- K262783 — RadiForce MX247W
- K254217 — Aerloom
- K260387 — SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)
- K260488 — MULTIX Impact; MULTIX Impact C
- K260767 — Facial Beauty Device (Facial Mask LED Beauty Device A-901 +2 more
- K261403 — Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter
- K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)
- K261718 — EZFluence (RADEZ V2)
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
- K262747 — ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0
- K262788 — Nova HD+
- K253630 — Mpact 3D Metal Foam
- K253954 — X-Guide Surgical Navigation System
- K254261 — Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)
- K260045 — cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190) +1 more
- K260047 — cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190) +1 more
- K260203 — Fule Vertebroplasty Balloon Catheter
- K260343 — Carescape Canvas 1000; Carescape Canvas Smart Display
- K260517 — Automatic Core Biopsy Instrument
- K260617 — Tigertriever 13 Ultra Revascularization Device
- K261176 — Zoom 4S Catheter
- K261378 — Rayvolve AZchest
- K261582 — Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)
- K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more
- K262013 — Kiba CTO Crossing Catheter
- K262722 — Primal K-Wire (P99-193-1410)
- K262735 — LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
- K253859 — Scarlet Pro (Scarlet Pro)
- K260401 — EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
- K260481 — GC85A
- K260545 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System +2 more
- K260711 — Accelagen Plus Surgical Matrix, 1cc (CG-01AP) +4 more
- K260751 — 35 Helix Guidewire
- K260824 — Gastrointestinal Videoscope Olympus GIF-2T1500
- K260856 — Disposable Distal Attachment D-201-13404
- K260870 — Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)
- K261360 — EasyCare Tx 2
- K261802 — Glidewell Denture Base Resin
- K261821 — 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)
- K262104 — Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)
- K262268 — Optiflow Oxygen Kit (AA484J)
- K262654 — Dexus Prosthetic System (MSL2, MSR2)
- K262677 — Iconix Knotless T
- K262744 — GenesisX RMN
- K253715 — Edi Catheter ENFit 6Fr/48 cm (6893166) +7 more
- K253877 — StimTrial Neuromodulation System
- K254103 — HOPKINS Telescopes for Arthroscopy
- K260407 — Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns
- K260733 — MRIA Radiation Therapy Information System (MRIA)
- K260811 — Heartvue.Proton
- K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor
- K261142 — Ponto 5 Mini; Ponto 5 Superpower
- K261153 — LithoVue Elite Digital Flexible Ureteroscope System
- K261394 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)
- K262581 — GraftGun Universal Graft Delivery System (GDS®)
- K262595 — VariLift-C Cervical Interbody Fusion System
- DEN250049 — Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
- K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray
- K252535 — Inno-Switch Laparoscopic Instruments
- K253879 — MONOFIX PDO
- K254304 — iNOS intraoral biosensor
- K261514 — Calcium Hydroxide Temporary Filling Material (KP-Cal)
- K261595 — Ceevra Reveal 4
- K261719 — Promisemed X-Safety Pen Needle
- K261747 — Report Studio
- K262631 — Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)
- K253515 — Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments
- K254027 — Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)
- K254286 — Guided Bone Regeneration System
- K260106 — OsteoCoil GT Active Compression System
- K260246 — SEISMIQ Intravascular Lithotripsy System
- K260604 — BiWaze Clear System
- K261381 — TiLink-L SI Joint Fusion System
- K260691 — BTL-699
- K253910 — Stitch - Suture Wires and Tapes
- DEN250026 — Avulux
- DEN250067 — ReneuRx (Neural Ice)
- K253692 — AVVIGO+ Multi-Modality Guidance System
- K253699 — Tempus ECG-PH
- K253726 — uAngio AVIVA CX
- K253728 — EVOLUTION® AM BIOFOAM® Tibial System
- K253817 — IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La
- K260584 — BoneMRI
- K260643 — Cimilre Dual Max
- K261015 — Solo Scope Colonoscope System
- K261354 — Electric wheelchair (D03)
- K261466 — Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM
- K261710 — AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors
- K261882 — Pisces-SC Standalone Cervical Interbody System
- K262005 — Affera Integrated Mapping System
- K262074 — Any-Zircos
- K262089 — Disposable Warming Blanket
- K262127 — DS Core CBCT Anatomy
- K262538 — Artix MT; Artix Thin-Walled Sheath
- DEN250043 — Qoramatic Automated Stool Management
- K253807 — Valence InVent Xtend (CVG-4101-VXA)
Data sourced from openFDA. This site is unofficial and independent of the FDA.