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"
73–96 of 188
Search insights Median review: 30d Cleared: 100% Top manufacturer: Ultradent Products, Inc. Lead specialty: Dental
Cleared Dec 02, 2022
DropSafeTM SicuraTM
K223353 · FMI
Pikdare Spa
General Hospital · 30d
Cleared Nov 03, 2022
Tera Harz Clear
K223355 · NXC
Graphy, Inc.
Dental · 1d
Cleared Oct 20, 2022
eClinic Stethopod
K220099 · DQD
Homediagnostic, LLC
Cardiovascular · 281d
Cleared Sep 09, 2022
AMBARINO High-Class
K222723 · EBF
Creamed GmbH & Co. Produktions- Und...
Dental · 1d
Cleared Sep 01, 2022
Disposable Medical Masks
K221038 · FXX
Hantech Medical Device Co., Ltd.
General Hospital · 147d
Cleared Aug 11, 2022
TERA HARZ DENTURE
K222414 · EBI
Graphy, Inc.
Dental · 1d
Cleared Jul 15, 2022
OK Handpiece
K221814 · EFB
Jaintek Co.,Ltd
Dental · 23d
Cleared Jul 01, 2022
J-Temp
K221909 · EBF
Ultradent Products, Inc.
Dental · 1d
Cleared May 23, 2022
Smart Wireless Stethoscope
K220470 · DQD
Shanghai Hulu Devices Co., Ltd.
Cardiovascular · 94d
Cleared Apr 15, 2022
XD
K220779 · LLZ
Mirada Medical, Ltd.
Radiology · 29d
Cleared Mar 18, 2022
Merits P335 Powered Wheelchair
K220529 · ITI
Merits Health Products Co., Ltd.
Physical Medicine · 22d
Cleared Feb 22, 2022
VALO X, VALO X Accessory Lenses
K220471 · EBZ
Ultradent Products, Inc.
Dental · 4d
Cleared Feb 16, 2022
Apapro Desensitizer
K220419 · LBH
Sangi Co, Ltd.
Dental · 2d
Cleared Feb 09, 2022
Lucy Breast Pump
K213311 · HGX
Willow Innovations, Inc.
Obstetrics & Gynecology · 128d
Cleared Jan 13, 2022
PRESIDENT The Original
K220097 · ELW
Colt?ne/Whaledent AG
Dental · 1d
Cleared Dec 16, 2021
ArchForm Orthodontic Software System
K213916 · PNN
Archform, Inc.
Dental · 1d
Cleared Dec 11, 2021
Siam NTD+ Nitrile Powder-Free Examination gloves
K212085 · LZA
Siam Ntd Corporation Co., Ltd.
General Hospital · 162d
Cleared Dec 09, 2021
Disposable Medical Nitrile Examination Gloves (Model:XYS-001)
K213371 · LZA
Anhui Xinyisheng Medical Technology...
General Hospital · 58d
Cleared Sep 14, 2021
ANNE One
K211305 · DRG
Sibel, Inc.
Cardiovascular · 138d
Cleared Apr 29, 2021
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs...
K210944 · LZA
Harbour Health, LLC
General Hospital · 30d
Cleared Apr 28, 2021
Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse...
K210925 · GEX
Boston Scientific
Gastroenterology & Urology · 30d
Cleared Apr 22, 2021
Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
K202480 · BZR
Parker Hannifin
Anesthesiology · 237d
Cleared Mar 23, 2021
DIOnavi-Denture02
K210828 · EBI
Dio Corporation
Dental · 4d
Cleared Mar 17, 2021
BBX-PET Scanner
K210450 · KPS
Prescient Imaging, LLC
Radiology · 29d