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"
49–72 of 188
Search insights Median review: 30d Cleared: 100% Top manufacturer: Ultradent Products, Inc. Lead specialty: Dental
Cleared Jul 15, 2024
NeuroLF (Basic)
K241751 · KPS
Positrigo AG
Radiology · 27d
Cleared Apr 02, 2024
Calibra Abutment Resin Cement
K240888 · EMA
Dentsply Sirona
Dental · 1d
Cleared Apr 02, 2024
SnapshotNIR model KD205
K240601 · MUD
Kent Imaging, Inc.
General & Plastic Surgery · 29d
Cleared Mar 21, 2024
N2
K240754 · EIA
Megagen Implant Co., Ltd.
Dental · 1d
Cleared Mar 20, 2024
Peak Universal Bond
K240743 · KLE
Ultradent Products, Inc.
Dental · 2d
Cleared Mar 19, 2024
Amydi-med Disposable Non-invasive EEG electrodes
K240668 · GXY
Shenzhen Amydi-Med Electrics Tech...
Neurology · 11d
Cleared Mar 15, 2024
FORMA Composite (Shade A3D)
K240694 · EBF
Ultradent Products, Inc.
Dental · 1d
Cleared Mar 05, 2024
TERA HARZ CLEAR
K240597 · NXC
Graphy, Inc.
Dental · 1d
Cleared Oct 24, 2023
FilteredFlo Warming Blankets
K232638 · DWJ
Iob Medical, Inc.
Cardiovascular · 55d
Cleared Sep 21, 2023
CAREMIBRAIN
K232569 · KPS
General Equipment For Medical...
Radiology · 28d
Cleared Sep 01, 2023
InnerView LC
K232657 · EKX
Perimetrics, Inc.
Dental · 1d
Cleared Aug 18, 2023
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro -...
K232498 · EBC
Ultradent Product, Inc.
Dental · 1d
Cleared Aug 08, 2023
Disposable Medical Examination Nitrile Gloves
K232008 · LZA
Raxwell Industrial, LLC
General Hospital · 33d
Cleared Aug 04, 2023
iTEMPSHIELD
K232010 · FLL
Aion Biosystems, Inc.
General Hospital · 29d
Cleared Aug 04, 2023
LEGACY® IPC
K232006 · JOW
Ig Technology, Ltd.
Cardiovascular · 29d
Cleared Jul 07, 2023
Cleo
K232011 · NJM
American Orthodontics
Dental · 1d
Cleared Jun 07, 2023
Intimate Rose Vaginal Dilators
K231430 · HDX
Plus EV Holdings Dba Intimate Rose
Obstetrics & Gynecology · 21d
Cleared Jun 06, 2023
A-Line Advanced
K231635 · NJM
Biocetec Co., Ltd.
Dental · 1d
Cleared May 10, 2023
AMP by Method Mobility, AMP Plus (or +) by Method Mobility
K231032 · ITI
Method Mobility
Physical Medicine · 29d
Cleared Feb 23, 2023
Neuro20 Pro System
K223797 · NGX
Neuro20 Technologies
Physical Medicine · 66d
Cleared Feb 09, 2023
Okti
K230073 · GWQ
Compumedics Limited
Neurology · 30d
Cleared Jan 19, 2023
Medaica M1 Telehealth Stethoscope
K223166 · DQD
Medaica, Inc.
Cardiovascular · 104d
Cleared Jan 03, 2023
EZ-STIK Electrodes
K223775 · GXY
South Dakota Partners
Neurology · 18d
Cleared Dec 23, 2022
CIMILRE Free-T2 Plus
K221708 · HGX
Cimilre Co., Ltd.
Obstetrics & Gynecology · 193d