FDA 510(k) clearances — page 102
clearances on record, most recent first.
Clearances — page 102
10,101–10,200 of 176,479- K232189 — OrionXR
- K232462 — ThermPix Thermovisual Camera
- K232467 — CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
- K232487 — Provecta 3D Prime and Provecta 3D Prime Ceph
- K232827 — LightForce Orthodontic System
- DEN230021 — ensoETM
- K221640 — AlloMap Heart Molecular Expression Testing
- K222831 — CRYOcheck Factor VIII Deficient Plasma with VWF
- K223811 — Lung-CAD
- K230609 — NG Delivery Catheter
- K230735 — Ultimate rTMS; Yingchi rTMS
- K230750 — OSSIOfiber® Cannulated Trimmable Fixation Nail
- K232158 — GenX-CR
- K232485 — AMSCO 600 Steam Sterilizer
- K213767 — Endure ETCO2/02 Nasal Cannula
- K222938 — Ablation-fit
- K230598 — Stone Extraction Baskets
- K231011 — Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse
- K231112 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- K231317 — TrueBeam, TrueBeam STx, Edge, VitalBeam
- K231748 — Cartesion Prime (PCD-1000A/3) V10.15
- K231766 — Skyway Anterior Cervical Plate System
- K231892 — Definium Pace Select
- K232459 — Velacur
- K232526 — XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
- K223755 — i-STAT G cartridge with the i-STAT 1 System
- K230362 — Planar LED mate
- K230517 — Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)
- K230881 — Change Healthcare Cardiology Hemodynamics
- K231283 — SiteRite 9 Ultrasound System
- K231504 — TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System
- K231746 — VERIFY Spore Test Strip for S40 Sterilant Concentrate
- K232002 — Vantage® Total Ankle System
- K232154 — MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
- K232192 — Venus Versa PRO System
- K223864 — Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
- K213510 — IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA
- K222921 — Minuteful-kidney test
- K223621 — DeepXray
- K223827 — FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
- K223848 — Intrisound Tuned Lumen® 155 Hearing Aids
- K230310 — STAT Medical Device Lancing System
- K230372 — VitreJect Syringe
- K230535 — KARL STORZ Urological Laser Accessories
- K230661 — Zeta Cranial Navigation System
- K230890 — ISE Electrodes
- K231141 — STarFix Designer Software C0265
- K231146 — AliTight
- K231240 — MaxTack Motorized Fixation Device
- K231284 — OnPoint Augmented Reality Spine System
- K231335 — Cleerly ISCHEMIA
- K231471 — Air/Water Bottle Tubing, CO2 Source Tubing
- K231643 — Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
- K231720 — Sterile Hypodermic Needles for Single Use
- K231723 — Sterile Safety Hypodermic Needles for Single Use
- K231727 — Sterile Auto-Disable Syringes with/without Needle for Single Use
- K231729 — Sterile syringes for single use with/without needle
- K232166 — PreXion3D Expedition
- K232386 — ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6
- K232400 — VariSeed (v10)
- K232413 — Fusion Robotic Navigation System
- K232414 — Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post
- K232426 — Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts
- K232457 — Q-FIX ULTRA All-Suture Anchor
- K232686 — CorVista® System
- K221743 — Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes
- K222823 — AeroDVx Arm System
- K230049 — SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine +2 more
- K230644 — Signum opaque F
- K230649 — Arm Blood Pressure Monitor
- K231207 — CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
- K231542 — Digital Blood Pressure Monitor WBP Series
- K231687 — Gradual Dental Zirconia Blank
- K231800 — IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9
- K231828 — Pounce Sheath
- K231996 — Steriking® LT-Blueline Pouches with Tyvek®
- K231999 — Steriking® LT-Blueline Pouches with Tyvek®
- K232389 — Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue
- K232443 — Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
- DEN230006 — esolution
- K223575 — Phoenix ICON, Phoenix ICON GO
- K230024 — HI-EMT MAGSHAPE
- K230127 — Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible
- K230824 — IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
- K231717 — IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022
- K232482 — MAGNETOM Viato.Mobile
- K200583 — Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL
- K201869 — Ki Power Tilt System
- K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
- K221869 — BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
- K223684 — F&P 820 Humidification System
- K230743 — ICHOR 14F Embolectomy System
- K231819 — Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
- K232361 — Promaxo MRI System II
- K232691 — Polibond
- DEN230007 — LightStrike+ (MXSUV1-SL and MXSUV1-FT)
- K213273 — Brain Anesthesia Response Monitor (Bar Monitor)
- K213413 — Hemostatic Dressing
- K221601 — MS-39
- K222988 — neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical
Data sourced from openFDA. This site is unofficial and independent of the FDA.