FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

1,198 results for "regulatory technology services, llc"
1–24 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 29, 2026
Syngo Carbon Space (VA4)
K263048 · LLZ
Siemens Healthineers AG
Radiology · 29d
Cleared Sep 25, 2026
EVO X30 Diagnostic Ultrasound System
K263182 · IYN
Samsung Medison Co., Ltd.
Radiology · 14d
Cleared Sep 21, 2026
TriSalus TriNav Advance Infusion System
K253509 · KRA
Trisalus Life Sciences
Cardiovascular · 320d
Cleared Sep 18, 2026
Hyperdrive 35 Guidewire
K253146 · DQX
Rapid Medical , Ltd.
Cardiovascular · 358d
Cleared Sep 01, 2026
Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
K262774 · HGX
Guangdong Horigen Mother & Baby...
Obstetrics & Gynecology · 28d
Cleared Aug 13, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor...
K253425 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 316d
Cleared Aug 03, 2026
VueJect® Ultrasound Enhancing Agent Delivery System
K262115 · IZQ
Acist Medical Systems, Inc.
General Hospital · 41d
Cleared Jul 23, 2026
ImageGrid StreamVue
K262143 · LLZ
Candelis, Inc.
Radiology · 28d
Cleared Jul 10, 2026
Avara Viewer
K262120 · LLZ
Avara Software
Radiology · 17d
Cleared Jul 08, 2026
Denture Base Resin V2
K262300 · EBI
Formlabs Ohio, Inc.
Dental · 1d
Cleared Jul 07, 2026
Pulmonex II Xenon System (132-503)
K253942 · IYT
Mirion Technologies (Capintec), Inc.
Radiology · 210d
Cleared Jul 02, 2026
HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology
K261897 · FRG
O&M Halyard, Inc.
General Hospital · 27d
Cleared Jun 26, 2026
LightningWire Transseptal Puncture System (TPS)
K261745 · DXF
ElectroWire Medical
Cardiovascular · 30d
Cleared Jun 22, 2026
Health Line Tearaway Introducer
K261950 · DYB
Health Line International Corporation
Cardiovascular · 12d
Cleared Jun 03, 2026
VSP System (Titanium Palatal Splint)
K261826 · DZJ
3D Systems, Inc.
Dental · 2d
Cleared Apr 16, 2026
Hot Pink Pad Warming System
K260903 · DWJ
Xodus Medical, Inc.
Cardiovascular · 29d
Cleared Apr 10, 2026
Protaryx Transseptal Puncture Device (PTX2-001)
K260839 · DYB
Protaryx Medical, Inc.
Cardiovascular · 28d
Cleared Apr 07, 2026
Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
K260860 · LYZ
Basic Medical Technology, Inc.
General Hospital · 22d
Cleared Mar 10, 2026
Varios Combi Pro2
K260773 · ELC
Nakanishi, Inc.
Dental · 1d
Cleared Mar 10, 2026
Sonosite iLOOK Ultrasound System
K260595 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 15d
Cleared Mar 04, 2026
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module
K260365 · KNW
Devicor Medical Products, Inc.
General & Plastic Surgery · 28d
Cleared Mar 03, 2026
Bond-PR™ Universal Adhesive
K260682 · KLE
Premier Dental Products Company
Dental · 1d
Cleared Feb 27, 2026
HOTWIRE RF GUIDEWIRE (901XXX)
K260292 · DXF
Atraverse Medical
Cardiovascular · 29d
Cleared Feb 26, 2026
Enbio PRO
K260254 · FLE
Enbio Group AG
General Hospital · 30d