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"
1–24 of 188
Search insights Median review: 30d Cleared: 100% Top manufacturer: Ultradent Products, Inc. Lead specialty: Dental
Cleared Aug 20, 2026
Kneu Platform (V2)
K262515 · GYD
Kneu Health Digital , Ltd.
Neurology · 30d
Cleared Aug 03, 2026
XLITE
K260236 · IZL
GEMSS HEALTHCARE CO., LTD.
Radiology · 189d
Cleared Jul 31, 2026
NanoCeram Resin
K262681 · EBI
3BFAB TEKNOLOJI A.S.
Dental · 1d
Cleared Jul 24, 2026
VS-370CF, VS-370CT
K262152 · FCX
VISION MEDICAL Co., Ltd.
Gastroenterology & Urology · 29d
Cleared Jul 06, 2026
Plum Vagiceuticals™ Vaginal Moisturizing Suppositories
K261909 · NUC
Pcca, Inc.
Obstetrics & Gynecology · 28d
Cleared Jul 01, 2026
Transcend Bulk Fill Flowable Composite
K262228 · EBF
Ultradent Products, Inc.
Dental · 1d
Cleared Jun 03, 2026
BracePaste Prime Plus
K261840 · DYH
American Orthodontics
Dental · 1d
Cleared Apr 30, 2026
UltraEZ
K261404 · LBH
Ultradent Products, Inc.
Dental · 1d
Cleared Apr 27, 2026
Grandio disc multicolor
K261357 · EBF
Voco GmbH
Dental · 3d
Cleared Apr 27, 2026
Dura-Crown
K261356 · EBF
Hangzhou SHINING3D Dental Technology...
Dental · 3d
Cleared Apr 17, 2026
Dura-Arch
K261261 · EBG
Hangzhou SHINING3D Dental Technology...
Dental · 1d
Cleared Mar 18, 2026
APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
K260830 · LBH
Sangi Co, Ltd.
Dental · 5d
Cleared Mar 12, 2026
Liv Pre-lubricated Intermittent Catheter
K260502 · EZD
HR Healthcare
Gastroenterology & Urology · 27d
Cleared Mar 11, 2026
Venus Diamond
K260783 · EBF
Kulzer, LLC
Dental · 1d
Cleared Mar 10, 2026
Gemini NOVA 810+980 Soft Tissue Laser
K260765 · NVK
Azena Medical, LLC
Dental · 1d
Cleared Feb 23, 2026
SKIA-Head (Model: SKIA-ST00)
K253486 · LLZ
Skia, Inc.
Radiology · 129d
Cleared Feb 23, 2026
Profoject™ Insulin Syringes
K253068 · FMF
CMT Health PTE., Ltd.
General Hospital · 154d
Cleared Jan 29, 2026
EZ-Protect Hydrophilic Closed System Intermittent Catheter
K251274 · EZD
HR Healthcare
Gastroenterology & Urology · 280d
Cleared Jan 21, 2026
LumiCera
K260170 · EBF
Hangzhou SHINING3D Dental Technology...
Dental · 1d
Cleared Dec 23, 2025
VarioSurg 4
K254163 · DZI
Nakanishi, Inc.
Dental · 1d
Cleared Dec 22, 2025
Oxygen Concentrator-P2-O5E
K251764 · CAW
Qingdao Kingon Medical Science and...
Anesthesiology · 196d
Cleared Dec 19, 2025
iCEM Universal Plus
K254063 · EMA
Kulzer, LLC
Dental · 2d
Cleared Nov 21, 2025
TERA HARZ Hard Denture (THD-C-500)
K253681 · EBI
Graphy, Inc.
Dental
Cleared Oct 14, 2025
Demi Pro
K253461 · EBZ
Meta Systems Co., Ltd.
Dental · 7d