Search FDA 510(k) Devices

5,539 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
2809–2832 of 3,225
Cleared Feb 21, 2025
Custom Abutments
K243278 · NHA
Institut Straumann AG
Dental · 128d
Cleared Feb 21, 2025
LYMA Laser PRO
K243330 · OHS
Lyma Life , Ltd.
General & Plastic Surgery · 120d
Cleared Feb 21, 2025
Medicom Sterilization Pouch and Reel
K243431 · FRG
Medicom Asia-Pacific Holdings Ltd....
General Hospital · 108d
Cleared Feb 21, 2025
Sonio Suspect
K243614 · POK
Sonio
Radiology · 91d
Cleared Feb 21, 2025
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
K243637 · DZJ
Materialise NV
Dental · 88d
Cleared Feb 21, 2025
Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra...
K243640 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 88d
Cleared Feb 21, 2025
Primus Spinal Fixation System
K243916 · NKB
Spinal Elements, Inc.
Orthopedic · 63d
Cleared Feb 21, 2025
VITA YZ Multi Translucent
K243940 · EIH
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 63d
Cleared Feb 21, 2025
TEMP MASTER, PMMA-based dental resin
K243951 · EBG
Taiwan Dental Materials Co., Ltd.
Dental · 60d
Cleared Feb 21, 2025
Powered Mobility Scooter
K250027 · INI
Intradin (Shanghai) Machinery Co., Ltd.
Physical Medicine · 46d
Cleared Feb 21, 2025
Xpert® FII & FV
K250218 · NPR
Cepheid
Hematology · 28d
Cleared Feb 20, 2025
Medical diode laser systems (CHARISMA, REGAL)
K234004 · GEX
Reveal Lasers , Ltd.
General & Plastic Surgery · 429d
Cleared Feb 20, 2025
CORE Shoulder System
K241470 · QHE
LinkBio Corp.
Orthopedic · 272d
Cleared Feb 20, 2025
SperSort™ Sperm Sorting Chip (IPG02)
K241626 · MQK
Ipreg Incorporation
Obstetrics & Gynecology · 259d
Cleared Feb 20, 2025
CaRi-Plaque
K242240 · LLZ
Caristo Diagnostics , Ltd.
Radiology · 205d
Cleared Feb 20, 2025
Falcon HST
K242447 · OLV
Compumedics Limited
Neurology · 188d
Cleared Feb 20, 2025
NUSONO Handheld Ultrasound Scanner (NUSONO-C35)
K242681 · IYN
Nurodata, Inc.
Radiology · 167d
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
Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91)
K243086 · DQA
Unimed Medical Supplies, Inc.
Anesthesiology · 143d
Cleared Feb 20, 2025
Alinity h-series System
K243283 · GKZ
Abbott Laboratories
Hematology · 126d
Cleared Feb 20, 2025
CER-S
K243312 · DQK
Cardiocalm Srl
Cardiovascular · 121d
Cleared Feb 20, 2025
Arthrex FiberTape and TigerTape Cerclage Sutures
K243344 · JDQ
Arthrex, Inc.
Orthopedic · 118d
Cleared Feb 20, 2025
Dochek® Multi-Drug Urine Test Cup
K250067 · NGL
Guangzhou Decheng Biotechnology Co.,...
Toxicology · 41d
Cleared Feb 20, 2025
Defendo Fujifilm 700 Single Use Cleaning Adapter
K250140 · ODC
Steris Corparation
Gastroenterology & Urology · 34d