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"
193–216 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 24, 2021
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic...
K212704 · IYN
Philips Medical Systems
Radiology · 29d
Cleared Sep 20, 2021
SMILERS
K212961 · NXC
Biotech Dental Smilers, Sas
Dental · 4d
Cleared Sep 10, 2021
Surgical Mask
K212451 · FXX
Remade USA, LLC
General Hospital · 36d
Cleared Sep 02, 2021
Lung Image Analysis
K212494 · JAK
Pulmonx Corporation
Radiology · 24d
Cleared Sep 02, 2021
Air Relax Pro Model AR-4.0
K212491 · IRP
Diode Art Engineering Doing Business...
Physical Medicine · 24d
Cleared Aug 23, 2021
IMRIS iMRI 3T V
K212367 · LNH
Deerfield Imaging, Inc.
Radiology · 24d
Cleared Aug 06, 2021
Kosmos
K212100 · IYN
EchoNous, Inc.
Radiology · 31d
Cleared Aug 02, 2021
DynaCAD
K212175 · LLZ
Invivo Corporation
Radiology · 21d
Cleared Jul 25, 2021
MASC Surgical Mask
K211984 · FXX
Mid-America Safety Corp.
General Hospital · 30d
Cleared Jul 22, 2021
DC-Air and Athlos-1 and Athlos-Air
K211688 · MUH
Athlos OY
Radiology · 50d
Cleared Jul 20, 2021
ACUSON Sequoia Diagnostic Ultrasound System
K211859 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Jun 29, 2021
STAGE
K210843 · LNH
Spintech, Inc.
Radiology · 99d
Cleared Jun 25, 2021
3D Echo v1.1
K211656 · LLZ
Jointvue, LLC
Radiology · 28d
Cleared Jun 25, 2021
Vu-Path Ultrasound System
K203657 · IYN
Crystalline Medical
Radiology · 192d
Cleared Jun 16, 2021
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black,...
K211310 · LZA
Megine Industries Sdn Bhd
General Hospital · 47d
Cleared Jun 15, 2021
Amerishield Surgical Mask
K211520 · FXX
Premiumestore, LLC
General Hospital · 29d
Cleared Jun 04, 2021
Micro C Medical Imaging System, M01
K211473 · IZL
Oxos Medical, Inc.
Radiology · 23d
Cleared Jun 02, 2021
ASM-301 Level 3 Surgical Mask
K211440 · FXX
American Surgical Mask Company, LLC
General Hospital · 23d
Cleared May 28, 2021
Infant Phototherapy Equipment
K210289 · LBI
Bistos Co., Ltd.
General Hospital · 115d
Cleared May 26, 2021
Breast Volume Navigator (BVN) Model G-2000
K211098 · IYO
Metritrack, Inc.
Radiology · 43d
Cleared May 25, 2021
Air Relax Plus Model AR-3.0
K211460 · IRP
Diode Art Engineering Doing Business...
Physical Medicine · 14d
Cleared May 25, 2021
AirMax Procedure Mask
K211275 · FXX
Premiumestore, LLC
General Hospital · 28d
Cleared May 20, 2021
Quick-20m
K203331 · GWL
Cgx, LLC
Neurology · 189d
Cleared May 14, 2021
AcQGuide MAX Steerable Sheath
K211100 · DRA
Acutus Medical, Inc.
Cardiovascular · 31d