Search FDA 510(k) Devices

5,561 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
3529–3552 of 174,061
Cleared Feb 20, 2025
Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7,...
K250214 · IYN
Edan Instruments, Inc.
Radiology · 27d
Cleared Feb 20, 2025
Green Card Bowie-Dick Test (BD115)
K250172 · JOJ
Steritec Products, Inc. (A Getinge...
General Hospital · 30d
Cleared Feb 20, 2025
Defendo Fujifilm 700 Single Use Cleaning Adapter
K250140 · ODC
Steris Corparation
Gastroenterology & Urology · 34d
Cleared Feb 20, 2025
Dochek® Multi-Drug Urine Test Cup
K250067 · NGL
Guangzhou Decheng Biotechnology Co.,...
Toxicology · 41d
Cleared Feb 20, 2025
Arthrex FiberTape and TigerTape Cerclage Sutures
K243344 · JDQ
Arthrex, Inc.
Orthopedic · 118d
Cleared Feb 20, 2025
CER-S
K243312 · DQK
Cardiocalm Srl
Cardiovascular · 121d
Cleared Feb 20, 2025
Alinity h-series System
K243283 · GKZ
Abbott Laboratories
Hematology · 126d
Cleared Feb 20, 2025
Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91)
K243086 · DQA
Unimed Medical Supplies, Inc.
Anesthesiology · 143d
Cleared Feb 20, 2025
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
K242821 · QAS
Ever Fortune.Ai, Co., Ltd.
Radiology · 155d
Cleared Feb 20, 2025
NUSONO Handheld Ultrasound Scanner (NUSONO-C35)
K242681 · IYN
Nurodata, Inc.
Radiology · 167d
Cleared Feb 20, 2025
Falcon HST
K242447 · OLV
Compumedics Limited
Neurology · 188d
Cleared Feb 20, 2025
CaRi-Plaque
K242240 · LLZ
Caristo Diagnostics , Ltd.
Radiology · 205d
Cleared Feb 20, 2025
SperSort™ Sperm Sorting Chip (IPG02)
K241626 · MQK
Ipreg Incorporation
Obstetrics & Gynecology · 259d
Cleared Feb 20, 2025
CORE Shoulder System
K241470 · QHE
LinkBio Corp.
Orthopedic · 272d
Cleared Feb 20, 2025
Medical diode laser systems (CHARISMA, REGAL)
K234004 · GEX
Reveal Lasers , Ltd.
General & Plastic Surgery · 429d
Cleared Feb 19, 2025
Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
K250473 · EIA
Dci International, LLC
Dental
Cleared Feb 19, 2025
SuperBall-RC™
K244015 · MBI
Arcuro Medical , Ltd.
Orthopedic · 55d
Cleared Feb 19, 2025
A.L.P.S. Small Fragment Plating System
K243761 · HRS
Biomet Orthopedics
Orthopedic · 75d
Cleared Feb 19, 2025
OPTOVISION Endoscopic Light Source Unit
K243591 · OWN
Optosurgical, LLC
General & Plastic Surgery · 91d
Cleared Feb 19, 2025
Single Use CO2 Laser Fiber (HAF005001)
K243588 · GEX
Quanta System Spa
General & Plastic Surgery · 91d
Cleared Feb 19, 2025
Straumann InLab Validated Workflow
K243478 · NHA
Institut Straumann AG
Dental · 103d
Cleared Feb 19, 2025
Phasix ST Umbilical Hernia Patch
K243241 · OWT
Davol, Inc., A Subsidiary of C.R....
General & Plastic Surgery · 132d
Cleared Feb 19, 2025
Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4,...
K243206 · IRP
Sichuan Qianli-Beoka Medical...
Physical Medicine · 141d
Cleared Feb 19, 2025
Visby Medical Respiratory Health Test
K242526 · QOF
Visby Medical, Inc.
Microbiology · 177d