FDA 510(k) clearances — page 50
clearances on record, most recent first.
Clearances — page 50
4,901–5,000 of 176,479- K243376 — uAngio AVIVA CX
- K243532 — LumiRex Ureteroscope
- K243896 — LenSx Laser System (8065998162)
- K250030 — Flash Ultrasound System 5100 Point of Care
- K250158 — Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003)
- K250256 — Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))
- K250958 — APRO 55 Swift Catheter and Alembic Aspiration Tubing
- K250977 — Suture-TOOL System
- K251101 — AIRO Suction Unit (AIRO-01)
- K242321 — Kosmos
- K242469 — RFMagik Lite
- K243041 — contact forte Alpha
- K243082 — Infrared Thermometer
- K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
- K243400 — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test
- K243406 — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
- K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL) +1 more
- K243721 — Self Sealing Sterilization Pouches
- K243821 — i-Cut
- K243855 — BD Alaris Infusion System with Guardrails Suite MX
- K243861 — butterflyBVM
- K243876 — VERIFY STEAM Integrating Indicator
- K243998 — DCX Disposable Cassette (DCX)
- K244026 — PAL 7020 Console
- K250046 — Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)
- K250153 — Neu Platform
- K250289 — Intracavitary/Interstitial System
- K250426 — Amulet Steerable Delivery Sheath
- K250554 — prodisc® L Instruments
- K250608 — Mako Total Knee Application (3.0); Hybrid Tip Pointer
- K250723 — FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
- K250892 — CastleLoc Pectus Bar System
- K250909 — Prelude Wave Hydrophilic Sheath Introducer
- K251075 — DYNAMIS Implant System
- K251117 — Cervical Spine Truss System (CSTS)
- K233337 — Freespira Breathing System
- K242214 — Sonu
- K242514 — Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
- K242963 — MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs
- K242973 — CanMINI Hand and Foot System
- K243239 — Lung AI (LAI001)
- K243714 — da Vinci SP Surgical System (SP1098)
- K243945 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
- K243954 — PeriCross Epicardial Access Kit
- K250002 — Smart Check O2 (MA0236)
- K250116 — Arm Blood Pressure Monitor (4 models)
- K250183 — CO2 Laser System (CO2 Laser SST-L23)
- K250206 — Diode laser system (Night Universe; Predator)
- K250262 — GO-PEN®
- K242232 — Mpact 3D Metal Augments II
- K242531 — NOVEOS Specific IgE (sIgE) Assay +9 more
- K243326 — Dynamis Robotic Surgical System
- K243479 — EchoGuide (Version 1)
- K243697 — MySpine WebPlanner
- K250155 — Xpert Knee
- K250198 — Laon Ortho
- K250228 — eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)
- K250697 — Electric Nasal Aspirator (BC026, BC025, BC023)
- K250831 — Annalise Enterprise
- K250869 — Parietene Macroporous Mesh (PPM5050 )
- K250944 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl
- K241931 — OcuMet Beacon (OCUB100)
- K242247 — ARIX Femur Nail System
- K242542 — Medentika CAD/CAM Abutments
- K243343 — BD CTGCTV2
- K243386 — Ventris Intervertebral Body Fusion Device
- K243621 — Evoblock, Perléon
- K243944 — Aperta NSE PTA Balloon Dilatation Catheter
- K250669 — Adaptix Interbody System with Titan nanoLOCK Surface Technology
- K242254 — D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter
- K243383 — CHIKAI Nexus 014
- K243508 — Wearable breast pump (model S12A)
- K243651 — VersaViewer
- K243875 — Spectricept Skin and Wound Cleanser
- K250176 — DAND Dental Implant System
- K251196 — Composite Orthodontic Brackets and Buttons
- K240355 — FROG (Filter Removal of Glass)
- K240775 — PeriBeam® Pericardial Membrane
- K241188 — Acucy® Influenza A&B Test with the Acucy® 2 System
- K241996 — ULTRA 1040
- K242170 — K-ASSAY CRP (Ver.2)
- K243013 — LIAISON PLEX Gram-Negative Blood Culture Assay
- K243734 — Wireless/ Wired X-Ray Flat Panel Detectors
- K250146 — SofWave System
- K250224 — handLITE (TN19S)
- K250459 — DMRX 100ml Empty Container Solution +3 more
- K250481 — Extension Feeding Set with ENFit Connectors
- K250834 — Zimmer Biomet Ceramic Heads (22.2mm diameter)
- K250842 — PADLOCK CLIP EFTR Kit (00713229)
- DEN240062 — Minder System
- K242056 — miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus
- K242129 — VitalRhythm
- K242337 — FlowGuide (FG60F); GuidionShort (GS60F)
- K242992 — RayCare (2024A SP1)
- K243337 — Dental Cone Beam Computed Tomography System
- K243459 — Ultimate rTMS for OCD (M-series)
- K243460 — Ultimate rTMS
- K243750 — SimpleStitch Suturing System
- K243878 — CLARUS (700)
- K250270 — Luja Set
Data sourced from openFDA. This site is unofficial and independent of the FDA.