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
2713–2736 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 2025
Somfit D
K252383 · MNR
Compumedics Limited
Neurology · 28d
Cleared Aug 28, 2025
da Vinci SP Firefly Imaging System
K252350 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 30d
Cleared Aug 28, 2025
Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System
K252057 · QEW
Imperative Care, Inc.
Cardiovascular · 58d
Cleared Aug 28, 2025
RadiForce GX570
K252030 · PGY
Eizo Corporation
Radiology · 59d
Cleared Aug 28, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K252014 · JWY
Thermo Fisher Scientific
Microbiology · 62d
Cleared Aug 28, 2025
Proximity Anterior Cervical Plate System
K251965 · KWQ
Alphatec Spine, Inc.
Orthopedic · 63d
Cleared Aug 28, 2025
truFlex
K251594 · NGX
Syrma Johari Medtech Limited
Physical Medicine · 93d
Cleared Aug 28, 2025
CT:VQ
K251484 · JAK
4Dmedical Limited
Radiology · 106d
Cleared Aug 28, 2025
OTC 4-Channel Rechargeable TENS Unit
K251429 · NUH
Changsha Anxiang Medical Technology...
Physical Medicine · 112d
Cleared Aug 28, 2025
Definium Tempo Select
K250788 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 167d
Cleared Aug 28, 2025
Medical Gas Analyzer (AG200)
K250148 · CCK
Prior Care Science Technology, Ltd.
Anesthesiology · 219d
Cleared Aug 28, 2025
SmartPilot YpsoMate NS-A2.25
K243901 · QOG
Ypsomed AG
General Hospital · 252d
Cleared Aug 28, 2025
SV600, SV800 Ventilator
K243767 · CBK
Shenzhen Mindray Bio-Medical...
Anesthesiology · 265d
Cleared Aug 27, 2025
HOTWIRE RF GUIDEWIRE (901XXX)
K252419 · DXF
Atraverse Medical, Inc.
Cardiovascular · 26d
Cleared Aug 27, 2025
CLUNGENE Multi-Drug Test Easy Cup
K252118 · NFT
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 51d
Cleared Aug 27, 2025
Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)
K251752 · EOQ
Shanghai AnQing Medical Instrument...
Ear, Nose, Throat · 79d
Cleared Aug 27, 2025
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs,...
K251716 · LZA
Basic Medical Technology, Inc.
General Hospital · 84d
Cleared Aug 27, 2025
Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]
K251637 · MQL
Donnevie Medical Technology...
Obstetrics & Gynecology · 90d
Cleared Aug 27, 2025
Additively Manufactured Aligner Resin
K251415 · NXC
Aidite (Qinhuangdao) Technology Co.,...
Dental · 112d
Cleared Aug 27, 2025
Phoenix Sinus Tarsi Stent System
K251382 · HWC
Astra Orthomed, Inc.
Orthopedic · 117d
Cleared Aug 27, 2025
KnoxFog Anti-fogging Device
K251068 · OCT
Uv One Hygienics, Inc.
General & Plastic Surgery · 142d
Cleared Aug 27, 2025
VistaSoft 4.0 and VisionX 4.0
K250947 · QIH
Durr Dental SE
Radiology · 152d
Cleared Aug 27, 2025
Portable oxygen concentrator (W-R1(MAX))
K250625 · CAW
Nanjing Yinuoji Medical Technology...
Anesthesiology · 177d
Cleared Aug 27, 2025
QIAstat-Dx Respiratory Panel Plus
K250080 · QOF
QIAGEN GmbH
Microbiology · 226d