FDA 510(k) clearances — page 84
clearances on record, most recent first.
Clearances — page 84
8,301–8,400 of 175,620- K231160 — Cardio Q50, Cardio Q70
- K231447 — Double Internal Joint Stabilizer- Elbow
- K231478 — Digital Blood Pressure Monitor (Model: YB-800)
- K231700 — Ziehm Vision FD
- K231825 — Panther TPS
- K232095 — SeptiCyte RAPID
- K232130 — Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
- K232267 — Precice Max System
- K232384 — Videa Dental Assist
- K232394 — Internal Locking Plate and Screw Fixation System
- K232598 — Unscented Menstrual Tampon
- K232887 — Invisalign Palatal Expander System
- K232892 — Hp Detect Stool Antigen ELISA
- K232939 — IPL Hair Removal Device
- K232957 — Sterile and Non-Sterile Ultrasound Gels
- K233182 — Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)
- K233237 — xeo+ Family
- K233564 — FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)
- K233607 — MagnetOs Easypack Putty
- K233668 — Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)
- K233681 — ConFirm 20 Minute Incubator
- K233682 — VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
- K223470 — C50
- K230950 — ARTIS icono (VE30A)
- K231181 — bright CT
- K231570 — StrokeViewer Perfusion
- K231645 — PherDal® At-Home Insemination Kit
- K231721 — Disposable Hot Biopsy Forceps
- K231801 — MedHealth DVT compression Devices MHH900S/MHH900E
- K231887 — ARIX Ankle Distal Tibia System
- K232283 — PhySoftAMS®
- K232401 — Disposable Veress Needles
- K232455 — SofWave System
- K232580 — Disposable Endobronchial Blocker Tube
- K232875 — Vial Adapter 20mm
- K233227 — VELYS Robotic-Assisted Solution
- K233374 — Secret Pro
- K233647 — VersaCross Connect Transseptal Dilator
- K233648 — Millipede 088 Access Catheter
- K233670 — Ascension Silicone MCP; Ascension Silicone PIP
- K230742 — ACCLARENT AERA Eustachian Tube Dilation System
- 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; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx
- 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; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort isp M.R.I. ECG Enabled Implantable Port; PowerPort Slim ECG Enabled Implantable Port
Data sourced from openFDA. This site is unofficial and independent of the FDA.