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
2569–2592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 2025
Stethophone Pro
K252595 · DQD
Sparrow Acoustics, Inc.
Cardiovascular · 28d
Cleared Sep 12, 2025
LUX-Dx II Insertable Cardiac Monitor (M302)
K252593 · MXD
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Sep 12, 2025
CADDIE
K252586 · QNP
Odin Medical Limited
Gastroenterology & Urology · 28d
Cleared Sep 12, 2025
Legend X Platform
K252576 · GEI
Pollogen, Ltd.
Neurology · 29d
Cleared Sep 12, 2025
Spine & Trauma Navigation Instruments
K252562 · OLO
Brainlab AG
Orthopedic · 29d
Cleared Sep 12, 2025
Wisdiag Multi-Drug Urine Test Cup
K252554 · NFT
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 30d
Cleared Sep 12, 2025
PowerKnot High Strength Sutures
K252225 · GAT
Medacta International S.A.
General & Plastic Surgery · 58d
Cleared Sep 12, 2025
LED Light Therapy Mask (2311, 2344, 2457, 2458)
K252189 · OHS
Dongguan Yanxi Technology Co., Ltd.
General & Plastic Surgery · 60d
Cleared Sep 12, 2025
Vertex(TM) Catheter
K252027 · DYB
Jupiter Endovascular
Cardiovascular · 74d
Cleared Sep 12, 2025
Erchonia EVRL
K251843 · OLP
Erchonia Corporation
General & Plastic Surgery · 88d
Cleared Sep 12, 2025
ViewMateTM Ultrasound System
K251820 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 91d
Cleared Sep 12, 2025
Volta AF-Xplorer II
K251518 · DQK
Volta Medical
Cardiovascular · 119d
Cleared Sep 12, 2025
FETOLY
K251368 · IYN
Diagnoly
Radiology · 134d
Cleared Sep 12, 2025
Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and...
K251170 · FBN
Tangent Endoscopy, LLC
Gastroenterology & Urology · 150d
Cleared Sep 12, 2025
Compact II
K251083 · IPF
Enraf-Nonius, B.V.
Physical Medicine · 156d
Cleared Sep 12, 2025
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
K250986 · LHN
Mevion Medical Systems, Inc.
Radiology · 165d
Cleared Sep 12, 2025
DynaNail TTC Fusion System
K250628 · HSB
MedShape, Inc.
Orthopedic · 193d
Cleared Sep 12, 2025
Fast Warm - NX
K250445 · MQL
Fujifilm Irvine Scientific
Obstetrics & Gynecology · 210d
Cleared Sep 12, 2025
BD PhaSeal™ Optima Connecting Set (C83-O)
K250059 · ONB
Becton, Dickinson and Company
General Hospital · 245d
Cleared Sep 12, 2025
bite away two
K250047 · IRT
mibeTec GmbH
Physical Medicine · 245d
Cleared Sep 12, 2025
uWS-Angio
K250040 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 247d
Cleared Sep 12, 2025
BONX805
K243864 · IZL
Bontech Co., Ltd.
Radiology · 269d
Cleared Sep 11, 2025
SEFRIA™ Hydrocodone Oral Fluid
K252520 · DJG
Immunalysis Corporation
Toxicology · 31d
Cleared Sep 11, 2025
Nylon flexTAP(R)
K252374 · LRK
Airway Technologies D/B/A Airway...
Dental · 43d