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"
73–96 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 22, 2024
nordicMEDiVA
K243209 · LLZ
Nordicneurolab AS
Radiology · 21d
Cleared Oct 17, 2024
Ascent Cardiorespiratory Diagnostic Software
K242809 · BTY
Medical Graphics Corporation
Anesthesiology · 30d
Cleared Oct 16, 2024
Safe Secure Sterilization Pouches and Rolls
K242839 · FRG
Shenzhen Safesecure Medical Infection...
General Hospital · 27d
Cleared Aug 29, 2024
Grass® MR Conditional/CT Cup Electrodes
K242346 · GXY
Natus Manufacturing Limited
Neurology · 22d
Cleared Aug 21, 2024
Fraxel® FTX Laser System
K242142 · GEX
Solta Medical
General & Plastic Surgery · 30d
Cleared Aug 19, 2024
MT-Bone
K242432 · DZI
Mectron S.P.A.
Dental · 3d
Cleared Jul 22, 2024
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic...
K240704 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 130d
Cleared Jun 28, 2024
nordicMEDiVA
K241608 · LLZ
Nordicneurolab AS
Radiology · 24d
Cleared Jun 27, 2024
TENS&EMS units (SM9109A, SM9109B)
K241509 · NUH
Plexus Yoga, LLC Dba Chirp
Neurology · 30d
Cleared Jun 14, 2024
Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
K241407 · GEX
Bios S.R.L.
General & Plastic Surgery · 28d
Cleared May 28, 2024
SpiroSphere, SpiroSphereECG, CardioSphere
K223629 · BTY
Eresearchtechnology GmbH
Cardiovascular · 540d
Cleared May 08, 2024
Legend X Applicator VO
K240999 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 27d
Cleared May 01, 2024
HOTWIRE™ RF Guidewire
K240900 · DXF
Atraverse Medical
Cardiovascular · 30d
Cleared Apr 24, 2024
Image Management V15
K240822 · LLZ
Philips Medical Systems Technologies
Radiology · 30d
Cleared Apr 15, 2024
Glide (91000-GL-X)
K240884 · GXY
Infinite Biomedical Technologies, LLC
Neurology · 14d
Cleared Mar 15, 2024
APRO 55 Catheter
K234115 · DQY
Alembic, LLC
Neurology · 79d
Cleared Mar 06, 2024
Insulin Syringe
K233794 · FMF
Spm Medicare Pvt. , Ltd.
General Hospital · 99d
Cleared Feb 15, 2024
InVision™ 1.5 Surgical Theatre
K240157 · LNH
Deerfield Imaging, Inc.
Radiology · 27d
Cleared Dec 27, 2023
TriSalus TriGuideTM Guiding Catheter
K233858 · DQY
Trisalus Life Sciences
Cardiovascular · 22d
Cleared Dec 22, 2023
3M™ Transbond™ Orthodontic Adhesive
K234043 · DYH
3M Unitek Orthodontic Products
Dental · 1d
Cleared Dec 21, 2023
syngo Virtual Cockpit (VB10A)
K232744 · LLZ
Siemens Healthcare GmbH
Radiology · 105d
Cleared Dec 17, 2023
FlexCath Cross Transseptal Solution
K233691 · DYB
Acutus Medical, Inc.
Cardiovascular · 31d
Cleared Dec 12, 2023
TeleScan
K233634 · LLZ
Bb Imaging
Radiology · 29d
Cleared Dec 06, 2023
Sonosite LX Ultrasound System
K233597 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 28d