FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

188 results for "third party"
25–48 of 188
Search insights Median review: 30d Cleared: 100% Top manufacturer: Ultradent Products, Inc. Lead specialty: Dental
Cleared Sep 29, 2025
G-BLOCK
K253236 · EBF
Graphenano Dental S.L.
Dental
Cleared Sep 23, 2025
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
K253053 · EBF
Hangzhou SHINING3D Dental Technology...
Dental · 1d
Cleared Sep 15, 2025
Zener® (model ZEN-001-B1)
K252128 · FRA
Uvx, Inc.
General Hospital · 70d
Cleared Sep 03, 2025
SignalNED System (Model RE)
K251726 · OMC
Forest Devices, Inc.
Neurology · 90d
Cleared Aug 28, 2025
Somfit D
K252383 · MNR
Compumedics Limited
Neurology · 28d
Cleared Jul 25, 2025
Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle
K252033 · FMF
CMT Health PTE., Ltd.
General Hospital · 25d
Cleared May 21, 2025
SMARTDent
K251109 · LLZ
Ray Co., Ltd.
Radiology · 40d
Cleared May 07, 2025
Cary
K251111 · JCX
Excitus AS
General & Plastic Surgery · 26d
Cleared Apr 26, 2025
AIRO Suction Unit (AIRO-01)
K251101 · BTA
Cro, LLC
General & Plastic Surgery · 15d
Cleared Apr 25, 2025
Neu Platform
K250153 · GYD
Neuhealth Digital , Ltd.
Neurology · 94d
Cleared Mar 31, 2025
Denture Base Resin DT20
K250946 · EBI
Hangzhou SHINING3D Dental Technology...
Dental · 3d
Cleared Mar 14, 2025
AION TempShield™
K250401 · FLL
Aion Biosystems, Inc.
General Hospital · 30d
Cleared Mar 14, 2025
KOROT Blood Pressure Monitor (KOROT P3 Accurate)
K250091 · DXN
Korot Co., Ltd.
Cardiovascular · 59d
Cleared Feb 25, 2025
JLK-AILink
K250348 · LLZ
JLK, Inc.
Radiology · 19d
Cleared Feb 20, 2025
Falcon HST
K242447 · OLV
Compumedics Limited
Neurology · 188d
Cleared Feb 19, 2025
Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
K250473 · EIA
Dci International, LLC
Dental
Cleared Jan 23, 2025
CephNinja
K241819 · LLZ
Cyncronus, LLC
Radiology · 213d
Cleared Dec 05, 2024
Rapid Surgical Plan (RSP-SW-001)
K243447 · LLZ
Navbit Pty, Ltd.
Radiology · 28d
Cleared Nov 15, 2024
ArtiSeal Vessel Sealing System-ArtiSeal Instruments
K241138 · GEI
Livsmed, Inc.
General & Plastic Surgery · 205d
Cleared Nov 04, 2024
JLK-PWI
K242709 · LLZ
JLK, Inc.
Radiology · 56d
Cleared Oct 16, 2024
JLK-CTP
K242556 · LLZ
JLK, Inc.
Radiology · 49d
Cleared Sep 04, 2024
SignalNED System (Model RE)
K242306 · OMC
Forest Devices, Inc.
Neurology · 30d
Cleared Aug 27, 2024
Disposable Syringe (Kit)
K242212 · DXT
Nemoto Kyorindo Co., Ltd.
General Hospital · 29d
Cleared Aug 14, 2024
Intimate Rose Vaginal Dilators
K241748 · HDX
Plus EV Holdings Dba Intimate Rose
Obstetrics & Gynecology · 57d