FDA 510(k) clearances — page 93
clearances on record, most recent first.
Clearances — page 93
9,201–9,300 of 176,479- K230852 — HemosIL Chromogenic Factor IX
- K230964 — Power Wheelchair (N5909)
- K231039 — CLEARFIL Universal Bond Quick 2
- K231337 — EndeavorRx
- K231614 — MiroTract Wound Matrix
- K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
- K231803 — Neodent Implant System - Zirconia Implant System
- K231870 — CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
- K232063 — SaliPen
- K232077 — Atalante X
- K232231 — QP-Brain®
- K232237 — Tyto Insights for Wheeze Detection
- K232572 — Kalitec Navigated Instrument System
- K232652 — Anatomical Plating System (various)
- K232659 — Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
- K232680 — fMRI Hardware System
- K232863 — Radiant Renewal Skincare Wand (HD-15, HD-15A)
- K232877 — FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C Stand Alone System
- K233019 — AllTest Multi-Drug Rapid Test Cup +3 more
- K233594 — Genesys Spine 3DP AIS-C II Cervical Interbody System
- K233621 — NeuroStar Advanced Therapy System (Version 3.8)
- K233663 — N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
- K233688 — Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
- K233811 — DT Controlled Phototherapy Equipment
- DEN230027 — NaviCam ProScan
- K230872 — Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System
- K231669 — Ziehm Solo FD
- K232425 — Signature ONE System
- K232451 — Insulia Bolus Companion
- K232947 — SIRA RFA Electrosurgical Device
- K233037 — Sterile Hypodermic Needles for Single Use
- K233222 — Aygün Sterilization Container Systems
- K233455 — ARx MIS Spinal Screw System
- K233634 — TeleScan
- K233645 — StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
- K233646 — Intri24 Introducer Sheath (52-101)
- K233684 — TriALTIS Spine System
- K223340 — EDS Calculus Softener TURBO CR
- K223690 — iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
- K232096 — Transpara Density 1.0.0
- K232290 — INTELLIO SHIFT System
- K232303 — ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
- K232797 — Hygenix
- K232815 — Wrist Blood Pressure Monitor
- K232985 — 24HR513C
- K233248 — FARADRIVE Steerable Sheath
- K233693 — Nio Color 8MP (MDNC-8132)
- K221851 — Lumina-PTFE Titanium
- K223757 — Bonelogic
- K230722 — Eagle device
- K231061 — NeuroBlate System
- K231743 — F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System
- K231898 — DTX Studio Clinic (4.0)
- K231964 — Novii+ Wireless Patch System
- K232053 — SimpleSense-BP, SimpleSense-BP Software Application
- K232085 — DVAS (DVAS-M, DVAS-W)
- K232515 — Valkyrie Thoracic Fixation System
- K232517 — Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)
- K232737 — PowerPort ClearVUE Slim ECG Enabled Implantable Port +3 more
- K232750 — BTI Interna Prosthetic Components
- K232830 — Vibrant System
- K233261 — Global Modular Replacement System
- K233432 — 10F Sheath and Dilator Set
- K233654 — VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems
- K230137 — Reliance® Fusion Sterilization Wraps
- K231127 — S.I.N. Dental Implant System
- K231206 — DLP Silicone Coronary Artery Ostial Cannulae
- K231515 — MySpine Cervical Guides
- K231967 — ARi ExCon Implant System
- K232273 — RM Electrode (RMH 23-01)
- K232381 — LOGIQ Totus
- K232661 — Myocardial Strain Software Application
- K232761 — ProNephro AKI (NGAL)
- K232795 — Led Mask Platinum Exclusive MD
- K232846 — Light Based Hair Removal Device
- K233429 — OTS 25 (100-1)
- K222930 — Evolve Nitric Oxide Delivery System
- K230677 — Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)
- K230712 — SG Lanset I, SG Lancets, Soft Lancets
- K231125 — 2008T BlueStar Hemodialysis Machine
- K231465 — Q-Pad Test System
- K231675 — OneRF Ablation System
- K232206 — SOMATOM Pro.Pulse
- K232769 — BeaMed Laser Surgery Fibers
- K233042 — Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K233334 — Aquilion Serve SP (TSX-307B/1) V1.3
- K233521 — QT ECG (QTERD100)
- K233562 — LINQ II Insertable Cardiac Monitor
- K233597 — Sonosite LX Ultrasound System
- K222057 — THERMOCLICK
- K223170 — Electronic Blood Pressure Monitor, model: HTD6602US
- K230734 — Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)
- K231005 — Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2
- K231230 — Optina-4C (MHRC-C1N)
- K231615 — Disposable Endoscopic Bipolar
- K231923 — Liberty SI Lateral Implant System
- K232220 — SS Abutment System
- K232434 — BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit
- K232440 — Adravision Perio
- K232814 — Electronic Blood Pressure Monitor
Data sourced from openFDA. This site is unofficial and independent of the FDA.