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"
49–72 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 06, 2025
InVision™ 3T Recharge Operating Suite
K252239 · LNH
Imris Imaging, Inc.
Radiology · 20d
Cleared Jul 18, 2025
MF SC GEN2 Facial Toning System
K252218 · NFO
Micro Current Technology, Inc.
Neurology · 3d
Cleared Jul 10, 2025
Sonosite LX Ultrasound System
K251830 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 27d
Cleared Jul 07, 2025
CustomSurg OrthoPlanner
K251863 · LLZ
Customsurg AG
Radiology · 20d
Cleared Jun 20, 2025
FloPatch FP120
K251114 · DPW
Flosonics Medical
Cardiovascular · 70d
Cleared May 27, 2025
BEAUTIFIL II
K251578 · EBF
Shofu Dental Corporation
Dental · 5d
Cleared May 09, 2025
turbodent touch
K251425 · KOJ
Mectron S.P.A.
Dental · 1d
Cleared Apr 21, 2025
Composite Orthodontic Brackets and Buttons
K251196 · DYW
Ec Certification Service GmbH
Dental · 4d
Cleared Mar 20, 2025
Joylux Intimacy Gel (PG3100)
K242958 · NUC
Joylux, Inc.
Obstetrics & Gynecology · 176d
Cleared Feb 20, 2025
SparkTM Clear Aligner System
K250487 · NXC
Ormco Corporation
Dental · 1d
Cleared Feb 20, 2025
Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7,...
K250214 · IYN
Edan Instruments, Inc.
Radiology · 27d
Cleared Feb 03, 2025
Sonicaid Team3
K241368 · HGM
Huntleigh Healthcare , Ltd.
Obstetrics & Gynecology · 265d
Cleared Jan 22, 2025
Rio™ Drug Reconstitution Transfer Device
K243985 · LHI
Icu Medical, Inc.
General Hospital · 30d
Cleared Jan 17, 2025
VersaD Delivery Catheter
K242051 · QJP
Unity Medical, Inc.
Neurology · 189d
Cleared Jan 10, 2025
Erchonia Zerona® VZ8
K243811 · OLI
Erchonia Corporation
General & Plastic Surgery · 30d
Cleared Jan 03, 2025
Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™...
K250015 · DYH
Ormco Corporation
Dental · 1d
Cleared Dec 20, 2024
HPR Cordless Hygiene Handpiece
K243911 · EKX
Handpiece Headquarters
Dental · 1d
Cleared Dec 17, 2024
Sentinel Camera
K243664 · HKI
Ai Optics
Ophthalmic · 20d
Cleared Dec 09, 2024
Verily Numetric Retinal Camera
K242508 · HKI
Verily Life Sciences, LLC
Ophthalmic · 109d
Cleared Dec 06, 2024
SmartSiteTM Vented Vial Access Device
K243486 · LHI
Yukon Medical, LLC
General Hospital · 28d
Cleared Nov 19, 2024
Natus BrainWatch System
K242930 · OMC
Natus Medical Incorporated Dba...
Neurology · 56d
Cleared Nov 15, 2024
ACUSON Redwood Diagnostic Ultrasound System
K243299 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Nov 01, 2024
Legend X Desktop System
K243217 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 29d
Cleared Oct 29, 2024
Mammotome AutoCore™ Single Insertion Core Biopsy System
K243095 · KNW
Devicor Medical Products, Inc.
General & Plastic Surgery · 29d