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"
97–120 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 30, 2023
EPIQ Series Diagnostic Ultrasound System
K233545 · IYN
Philips Ultrasound, LLC
Radiology · 27d
Cleared Nov 09, 2023
VarseoSmile TriniQ
K233596 · EBF
Bego Bremer Goldschl?gerei Wilh....
Dental · 1d
Cleared Nov 03, 2023
Easycess Aspiration Pump
K233428 · JCX
Guangzhou Easycess Medical Co.,Ltd
General & Plastic Surgery · 23d
Cleared Nov 02, 2023
BASE290 LED Curing Light
K233518 · EBZ
Handpiece Headquarters
Dental · 1d
Cleared Nov 02, 2023
EpiZact
K233056 · FMF
Guidestar Medical Devices
Anesthesiology · 38d
Cleared Oct 12, 2023
Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
K232852 · DXF
Cross Vascular, Inc.
Cardiovascular · 28d
Cleared Oct 12, 2023
Cross Vascular RF Generator and Footswitch (optional accessory)
K232809 · GEI
Cross Vascular, Inc.
General & Plastic Surgery · 30d
Cleared Oct 11, 2023
Synq Software Version 1.3
K232981 · LNH
Synaptive Medical, Inc.
Radiology · 20d
Cleared Sep 29, 2023
3M™ Clarity™Aligners with Quick Attachments
K233257 · NXC
3M Company, Unitek Orthodontic Products
Dental · 1d
Cleared Sep 28, 2023
BeautiLink SA
K233161 · EMA
Shofu Dental Corporation
Dental · 1d
Cleared Sep 26, 2023
ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic...
K232617 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Sep 22, 2023
DX. Bond V Dental Bonding Adhesive
K232978 · KLE
Sino-Dentex Co., Ltd.
Dental · 1d
Cleared Sep 14, 2023
LightForce Orthodontic System
K232827 · NJM
Lightforce Orthodontics
Dental · 1d
Cleared Aug 18, 2023
Sleepiz One+
K223163 · DRT
Sleepiz AG
Cardiovascular · 315d
Cleared Jul 31, 2023
Altris IMS
K232088 · NFJ
Altris, Inc.
Ophthalmic · 18d
Cleared Jul 04, 2023
MemorialTM Gloves
K231740 · LZA
Us Glove Supply
General Hospital · 20d
Cleared Jun 07, 2023
Ambra PACS
K231360 · LLZ
Dicom Grid Dba Ambra Health
Radiology · 28d
Cleared May 22, 2023
3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)
K231464 · NXC
3M Company, Unitek Orthodontic Products
Dental · 3d
Cleared May 15, 2023
Combi Touch
K231391 · ELC
Mectron S.P.A.
Dental · 3d
Cleared May 02, 2023
TriSalus TriNav® LV Infusion System
K230957 · KRA
Trisalus Life Sciences
Cardiovascular · 28d
Cleared Apr 26, 2023
TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
K230829 · NUH
Chongqing Rob Linka Science and...
Neurology · 30d
Cleared Apr 11, 2023
Eagle S/Saevo Slim/D700 Slim
K230732 · MUH
Alliage S/A Industrias Medica...
Radiology · 26d
Cleared Mar 24, 2023
SmartMTA Capsule
K230797 · KIF
Sprig Oral Health Technologies, Inc.
Dental · 2d
Cleared Mar 21, 2023
Syngo Carbon Space VA30A
K230561 · LLZ
Siemens Healthcare GmbH
Radiology · 21d