FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
4417–4440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2025
ScanDiags Ortho L-Spine MR-Q
K242607 · QIH
Scandiags AG
Radiology · 171d
Cleared Feb 21, 2025
Fassier-Duval Telescoping IM System
K241983 · HSB
Orthopediatrics Canada Ulc Dba Pega...
Orthopedic · 228d
Cleared Feb 21, 2025
Extremity Medical External Fixation System
K241563 · KTT
Extremity Medical, LLC
Orthopedic · 266d
Cleared Feb 21, 2025
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC
K241555 · MQV
Rti Surgical, Inc.
Orthopedic · 266d
Cleared Feb 21, 2025
Synthetic Bone Graft Particulate
K241186 · LYC
Shenzhen Dazhou Medical Technology...
Dental · 298d
Cleared Feb 20, 2025
SparkTM Clear Aligner System
K250487 · NXC
Ormco Corporation
Dental · 1d
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