FDA 510(k) clearances — page 260
clearances on record, most recent first.
Clearances — page 260
25,901–26,000 of 176,542- K181002 — Atellica IM BRAHMS Procalcitonin (PCT)
- K181016 — Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
- K181019 — Diode Laser System
- K181115 — CxHA PEEK Cervical IBF System
- K181300 — Embosphere Microspheres
- K181600 — PathLoc-SI Joint Fusion System
- K181029 — Solana Bordetella Complete Assay
- K171550 — Sterile Latex Surgical Gloves, Powder Free
- K171880 — IRRAflow CNS System
- K172440 — Solax Electric Scooter, Models: S302121, S302131, S302141, S302151
- K172987 — Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)
- K173340 — Yikang Latex Foley Catheter
- K173556 — Injection Screw
- K173909 — Dimension Hemoglobin A1c Assay
- K180011 — Pulmonx Chartis Tablet Console
- K180654 — PINXEL-RF system
- K180655 — Viking Lumbar Polyaxial Screw System
- K180673 — Normandy VBR System
- K181063 — Kestrel Buttress Plate System
- K181134 — GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral Spray
- K181556 — EliA M2 Immunoassay
- K181565 — Aquarius 8600 Digital Radiography Sensor
- K181586 — Tinnitus Sound Generator Module
- K171274 — ADVIA Centaur High-Sensitivity Troponin I (TNIH)
- K172874 — Infrared Thermometer
- K173206 — SEKURE HbA1c Assay
- K173511 — ActiveCare TD-4121 Blood Glucose Monitoring System
- K173627 — Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
- K180552 — Modified Novy Cornual Cannulation Set
- K180575 — THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X
- K180613 — Estelite Universal Flow
- K180695 — FBC 921 (ALIF)
- K181011 — AIM2
- K181043 — StatStrip Glucose Hospital Meter System
- K181276 — CONOD Enteral Feeding Sets
- K181287 — Catalyst CSR Shoulder System
- K172543 — High-speed Turbine Handpieces for Single Use
- K173486 — NTU-USB Ultrasound USB Box
- K173631 — Intelli-C
- K173801 — Transcranial Doppler Ultrasound System
- K173881 — Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G
- K173969 — Medicalgorithmics Unified Cardiac Rehabilitation System
- K180024 — SALVATION Midfoot Nail
- K180314 — Infrared Thermometer
- K180725 — Aspire Introducer Needle
- K180730 — INVISION Total Ankle Revision System
- K180816 — Ziehm RFD 3D Tracker
- K180963 — ROCCIA ALIF, ROCCIA TLIF
- K180967 — Dental Diode Laser System
- K181523 — Syneron CO2RE System
- K181697 — 16ch Foot/ Ankle SPEEDER
- K172991 — Advanced Dental Applicance
- K173039 — TruMatch CMF Titanium 3D Printed Implant
- K173274 — Ceevra Reveal 2.0
- K180289 — 3D Bolus Software
- K180697 — Pseudo-Patient
- K180900 — LED Light Therapy Device
- K180970 — Disposable guides KDNG00
- K181201 — Synermed ISE Reagents
- K181244 — Zavation Cervical Plate System
- K181246 — Zavation IBF System
- K181572 — Workflow Box
- K181574 — Uscan
- K181700 — HardyDisk AST Plazomicin 30ug (PLZ30)
- K173562 — Straumann Jason Membrane
- K180798 — Prime Acetabular Cup System
- K180923 — Personal Lubricating Jelly
- K180930 — EMPOWR VVC TIBIAL INSERT
- K181261 — Curiteva Cervical Interbody Fusion System
- K181522 — PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope
- K181547 — FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)
- K172971 — BMLS16-1
- K173766 — PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs
- K172694 — Sterile Disposable Syringes
- K173019 — GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar
- K173659 — Howell D.A.S.H Extraction Balloon with Multiple Sizing
- K173776 — BIOLOX delta Option and Extra-long Heads
- K173927 — Elecsys BRAHMS PCT
- K173970 — Materialise PKA Guide System
- K180515 — GammaTile
- K180590 — Tyber Medical PT Interbody Spacer System
- K180755 — Vail ALIF Buttress Plate System
- K180868 — Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set
- K181092 — CHROMID CARBA agar (CARB)
- K181139 — OLYMPIC Posterior Spinal Fixation System
- K181327 — InPen Dose Calculator
- K181350 — ASTRA-OCT Spine System
- K181499 — DRI Cocaine Metabolite Assay
- K181509 — Endorate Valve Sets
- K161085 — Nitrile Patient Examination Powder Free Glove, Textured, Black
- K172778 — CheckMyHeart Plus
- K173277 — ASAHI PTCA Guide Wire ASAHI SION black
- K173359 — Fractional CO2 Surgical Laser System
- K173721 — SureForm 60 and SureForm 60 Reloads
- K180018 — Disposable Hot Biopsy Forceps
- K181044 — 400um Perforator and Accessory Vein Ablation Kit
- K181175 — 12F Tri-Flow Triple Lumen Catheter
- K181493 — FilmArray Blood Culture Identification (BCID) Panel
- K180705 — Riptide Aspiration System React 68 Catheter
- K180715 — React 68 Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.