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
6025–6048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 2024
RibFix Titan™ Fixation System
K241282 · HRS
Riverpoint Medical
Orthopedic · 104d
Cleared Aug 19, 2024
Histolog® Scanner (Hardware 2.4, Software 3.3)
K241275 · OWN
Samantree Medical SA
General & Plastic Surgery · 105d
Cleared Aug 19, 2024
Negative Pressure Wound Therapy Device (V-Move, V-Grand)
K241023 · OMP
Med Way, Inc.
General & Plastic Surgery · 126d
Cleared Aug 19, 2024
OmniTrans Transport System
K240235 · JSM
Shenzhen Dakewe Bio-Engineering Co.,...
Microbiology · 203d
Cleared Aug 17, 2024
BTL-899MS
K240234 · IPF
BTL Industries, Inc.
Physical Medicine · 201d
Cleared Aug 16, 2024
HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT...
K242239 · NQQ
Gentuity, LLC
Cardiovascular · 17d
Cleared Aug 16, 2024
ACL TOP Family 50 Series (ACL TOP 750
K242127 · GKP
Instrumentation Laboratory (IL) Co.
Hematology · 28d
Cleared Aug 16, 2024
Ambu® aScope™ 5 Uretero (Standard Deflection)
K242108 · FGB
Ambu A/S
Gastroenterology & Urology · 29d
Cleared Aug 16, 2024
KLS Martin Oral-Max Implants MR Conditional (bundled)
K241314 · JEY
KLS-Martin L.P.
Dental · 98d
Cleared Aug 16, 2024
XTRA Collection sets
K241236 · CAC
Sorin Group Italia S.R.L.
Cardiovascular · 106d
Cleared Aug 16, 2024
SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G,...
K240978 · HIH
MacroLux Medical Technology Co., Ltd.
Obstetrics & Gynecology · 128d
Cleared Aug 16, 2024
qCT LN Quant
K240740 · QIH
Qure.Ai Technologies
Radiology · 151d
Cleared Aug 16, 2024
iTero Lumina™ Pro
K240573 · NTK
Align Technology , Ltd.
Dental · 168d
Cleared Aug 16, 2024
VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
K240307 · MQF
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology · 196d
Cleared Aug 16, 2024
Xenograft Bovine Bone Particulate
K240133 · NPM
Collagen Solutions, LLC
Dental · 211d
Cleared Aug 16, 2024
Human Lubricant
K240081 · NUC
Jiangxi Wulinxiang Biological...
Obstetrics & Gynecology · 218d
Cleared Aug 16, 2024
JDentalCare Dental Implant System: JDEvolution
K233896 · DZE
Jdentalcare Srl
Dental · 249d
Cleared Aug 16, 2024
HeartKey® Rhythm
K233755 · DQK
B-Secur Limited
Cardiovascular · 268d
Cleared Aug 16, 2024
Avicenna Roboflex
K233700 · FGB
Elmed Elektronik VE Medikal Sanayi VE...
General & Plastic Surgery · 273d
Cleared Aug 16, 2024
Sapphire NC ULTRA Coronary Dilatation Catheter
K233499 · LOX
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 290d
Cleared Aug 16, 2024
Mecun SpO2 sensor
K231979 · DQA
Shenzhen Mecun Medical Supply Co., Ltd.
Anesthesiology · 408d
Cleared Aug 16, 2024
BOSS™
K223700 · MXK
Intelon Optics, Inc.
Ophthalmic · 613d
Cleared Aug 16, 2024
VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood...
K222126 · NBW
Vivachek Biotech (Hangzhou) Co., Ltd.
Chemistry · 760d
Cleared Aug 15, 2024
Reusable Interface Cable 1.5 m (PRD-IFC-002)
K242061 · KNS
Creo Medical, Ltd.
Gastroenterology & Urology · 31d