FDA 510(k) clearances — page 85
clearances on record, most recent first.
Clearances — page 85
8,401–8,500 of 176,479- K233713 — Pilling Tracheostomy Tubes
- K240225 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
- K240522 — Esophageal TTS Stent
- K240540 — uMR Omega
- K240690 — STRUXXURE® MCS Anterior Cervical Plate System
- K240715 — Idys® C ZP 3DTi
- K230088 — Ankle Truss System (ATS)
- K232439 — Electrical Stimulator System
- K232568 — IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories
- K233665 — DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System
- K233753 — AI-Rad Companion (Pulmonary)
- K233926 — accufit
- K233980 — ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
- K234006 — AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test
- K234062 — APTUS Hand Scaphoid Plates
- K234081 — RedDrop ONE (One)
- K240122 — Normatec Elite
- K240179 — Medical Diode Laser (Model: L2)
- K240253 — Reach Needle
- K240309 — Tandem Mobi insulin pump with interoperable technology
- K240530 — DynaNail Mini Tapered Hybrid
- K240754 — N2
- K231974 — PATHFAST®hs-cTnI-II
- K232125 — V-PVP
- K232654 — Nephron Nitrile, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)
- K233002 — BEED 2,5, BEED 3,8
- K233375 — Tranquil-L Interbody System
- K233642 — InMode RF System
- K233901 — Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)
- K234047 — Automatic Registration
- K234049 — Straumann® BLC and TLC Implants - Line extension
- K234052 — Access Ferritin
- K234090 — EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)
- K234130 — Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O
- K240165 — Aneroid Sphygmomanometer with Stethoscope
- K240507 — NuVasive AttraX Scaffold
- K240537 — SMARTXIDE PRO
- K240574 — BruxZir® Radiant
- K240743 — Peak Universal Bond
- K231719 — Medical Surgical Mask
- K231843 — ARX Viral Transport Media Collection and Transport System
- K232619 — MATRIX HA PEEK Cervical IBF System
- K232682 — Pre-Sintered Zirconia Coloring Liquid
- K233146 — Blood Pressure Monitor
- K233772 — Disposable Dual Action Tissue Closure Device
- K234024 — HWJECT Auto-disable syringe
- K240668 — Amydi-med Disposable Non-invasive EEG electrodes
- K233599 — X-Clever (ASHK100G)
- K233660 — nCommand Lite System
- K240113 — CORIOGRAPH Knee Pre-Op Plan
- K240139 — Real Intelligence CORI
- K240515 — uNion® MAX Cervical Plate System
- K230981 — Meriglu Topical Skin Adhesive
- K230802 — Xprecia Prime Coagulation System
- K231856 — TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
- K232234 — Nouvo Safety Set
- K232327 — Endorail
- K233307 — Intensity Pulsed Light Therapy System
- K233342 — CINA-ASPECTS
- K233747 — Concha Sol Hearing Aids (CL-1001)
- K233748 — CIARTIC Move (VB10)
- K233799 — Wrist Blood Pressure Monitor (5 models)
- K233814 — 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD) +3 more
- K233881 — ivWatch® Model 400
- K233986 — BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL)
- K234104 — PICOANDY (Q-Switched Nd:YAG Laser)
- K234115 — APRO 55 Catheter
- K240112 — Light Cure Composite
- K240117 — Aventus Thrombectomy System (IM-2001/IM-0002)
- K240430 — Otoport Pro
- K240441 — MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw
- K240454 — RESPONDER® Polysaccharide Hemostat
- K240466 — STARband 3D
- K240539 — Vital Spinal Fixation System
- K240694 — FORMA Composite (Shade A3D)
- K231529 — CloudPoint FastDesign Chairside
- K231850 — QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments
- K232301 — Define RF Microneedling System
- K232567 — Myriad SPECTRA Light Source
- K232610 — da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation
- K232803 — NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
- K232980 — SpermAlign Sperm Separation Device
- K233542 — Ortho Guidance Precision Knee Software +3 more
- K233853 — LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub
- K233958 — hekaDrill
- K232022 — CAS-One IR
- K233070 — Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
- K233136 — Hygeia Express Powered Breast Pump
- K233466 — Edison System
- K233592 — BioPoly Radial Head Implant
- K233930 — MRCP+ version 2 (MRCP+ v2)
- K233946 — IMMULITE® 2000 BR-MA
- K233949 — ACCORD Cable System
- K233952 — DEKA ACE Pump System
- K233968 — CINA-iPE
- K234002 — ICEfx Cryoablation System (FPRCH8000-02)
- K234008 — CERAMENT G
- K234055 — DEKA Loop
- K231849 — MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A +1 more
- K232564 — Align Studio
Data sourced from openFDA. This site is unofficial and independent of the FDA.