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"
25–48 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 19, 2026
Portable Dental X-ray Device (GT-1)
K254018 · EHD
Guilin Refine Medical Instrument Co.,...
Radiology · 66d
Cleared Jan 26, 2026
Ascent3T Neonatal Magnetic Resonance Imaging System
K253499 · LNH
Eyas Medical Imaging, Inc.
Radiology · 89d
Cleared Dec 30, 2025
AnyScan 3.0 NM Scanner Family
K253844 · KPS
Mediso Medical Imaging Systems, Ltd.
Radiology · 28d
Cleared Dec 23, 2025
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
K253740 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 29d
Cleared Dec 12, 2025
Fundus On Phone Non Mydriatic (FOP NM-10)
K252120 · HKI
Remidio Innovative Solutions Private...
Ophthalmic · 158d
Cleared Nov 20, 2025
syngo.MR Applications (VB80)
K253495 · LLZ
Siemens Healthineers AG
Radiology · 23d
Cleared Nov 17, 2025
ACUSON Maple Diagnostic Ultrasound System
K253487 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Nov 13, 2025
ACUSON Juniper Diagnostic Ultrasound System
K253457 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 38d
Cleared Nov 07, 2025
MultiMatch Flow Chameleon AntiMicrobial Composite
K253513 · EBF
Premier Dental Products Company
Dental · 1d
Cleared Nov 06, 2025
Motive™ Muscle Stimulator for Lower Back (OT01-1003)
K253478 · NGX
Motive Health, Inc.
Physical Medicine · 23d
Cleared Nov 06, 2025
Adaptix Ortho350
K252133 · IZF
Adaptix Limited
Radiology · 122d
Cleared Nov 03, 2025
Sonosite MT Ultrasound System
K253448 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 32d
Cleared Oct 31, 2025
Hydro Print Premium Fast Set - 454g (1lb) (052037)
K253501 · ELW
Vigodent Ind?stria E Comercio Ltda
Dental · 1d
Cleared Oct 16, 2025
Re:Balans
K243727 · DSB
Mode Sensors AS
Cardiovascular · 317d
Cleared Sep 26, 2025
Planmed XFI
K250318 · SFV
Planmed OY
Radiology · 234d
Cleared Sep 19, 2025
UniBur
K252662 · HBE
Nakanishi, Inc.
Neurology · 28d
Cleared Sep 16, 2025
Medline Microtek C-Flo Bag Decanter, Sterile (2000S)
K251676 · LHI
Microtek Medical, LLC
General Hospital · 109d
Cleared Sep 12, 2025
Legend X Platform
K252576 · GEI
Pollogen, Ltd.
Neurology · 29d
Cleared Sep 09, 2025
AI-Rad Companion Prostate MR
K252608 · LLZ
Siemens Healthcare GmbH
Radiology · 22d
Cleared Aug 28, 2025
Powder-Free Vinyl Exam Gloves, clear
K252505 · LYZ
Basic Medical Technology, Inc.
General Hospital · 20d
Cleared Aug 27, 2025
HOTWIRE RF GUIDEWIRE (901XXX)
K252419 · DXF
Atraverse Medical, Inc.
Cardiovascular · 26d
Cleared Aug 18, 2025
PnueAira (PNCU-01)
K251086 · JOW
Biotab, LLC
Cardiovascular · 131d
Cleared Aug 12, 2025
HOTWIRE™ System RF Generator and Footswitch (optional accessory)
K252083 · GEI
Atraverse Medical, Inc.
General & Plastic Surgery · 41d
Cleared Aug 08, 2025
Coretech Compression System (Coretech RHB3003)
K250817 · JOW
Vive Health, LLC
Cardiovascular · 143d