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"
481–504 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 30, 2015
Philips Lumify Diagnostic Ultrasound System
K152899 · IYN
Philips Healthcare, Inc.
Radiology · 29d
Cleared Oct 21, 2015
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound...
K152763 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 27d
Cleared Oct 16, 2015
ELTRAC 471
K151640 · ITH
Enraf-Nonius, B.V.
Physical Medicine · 120d
Cleared Oct 06, 2015
ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System
K152369 · IYN
Siemens Medical Solutions USA, Inc....
Radiology · 46d
Cleared Oct 02, 2015
DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems
K152545 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 24d
Cleared Sep 21, 2015
ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System
K152469 · IYN
Siemens Medical Solutions, Inc.,...
Radiology · 21d
Cleared Sep 03, 2015
SpeqRT
K152250 · IYN
Signostics Limited
Radiology · 24d
Cleared Aug 20, 2015
HealthMyne PACS
K152186 · LLZ
Healthmyne, Inc.
Radiology · 15d
Cleared Aug 19, 2015
FUJIFILM SonoSite X-Porte Ultrasound System
K152209 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 12d
Cleared Aug 12, 2015
RS80A Diagnostic Ultrasound System
K151663 · IYN
Samsung Medison Co., Ltd.
Radiology · 54d
Cleared Aug 07, 2015
Confida Adaptive Sheath
K152054 · DYB
Medtronic, Inc.
Cardiovascular · 15d
Cleared Jul 31, 2015
SmartSite Vented Vial Access Device
K151963 · LHI
Yukon Medical, LLC
General Hospital · 15d
Cleared Jul 29, 2015
3D/5D Viewer
K151808 · LLZ
Samsung Medison Co., Ltd.
Radiology · 27d
Cleared Jul 27, 2015
BD Angiocath IV Catheter, BD Insyte IV Catheter
K151698 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 33d
Cleared Jul 17, 2015
Hi-Light Diagnostic Ultrasound Systems
K151709 · IYO
Qingdao Hisense Medical Equipment...
Radiology · 23d
Cleared Jul 07, 2015
Dentrix Ascend Imaging
K151438 · LLZ
Realcloud Imaging, Inc.
Radiology · 39d
Cleared Jun 26, 2015
Plato MICROCATH 27B Microcatheter
K143398 · DQO
Scientia Vascular, LLC
Cardiovascular · 212d
Cleared Jun 25, 2015
GSI TympStar Pro Middle Ear Analyzer
K151509 · ETY
Diagnostic Group, Dba Grason-Stadler
Ear, Nose, Throat · 21d
Cleared Jun 23, 2015
LiverMultiScan
K143020 · LNH
Mirada Medical, Ltd.
Radiology · 246d
Cleared Jun 12, 2015
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S
K150080 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 148d
Cleared May 22, 2015
MicroTaper Needle Introducer Set
K151076 · DRE
Summit Access, LLC
Cardiovascular · 30d
Cleared May 15, 2015
ZONARE ZS3 Diagnostic Ultrasound System
K151175 · IYN
Zonare Medical Systems, Inc.
Radiology · 14d
Cleared May 15, 2015
Flexicare Heated Wire Breathing Systems
K150900 · BZE
Flexicare Medical, Ltd.
Anesthesiology · 42d
Cleared May 09, 2015
Terason uSmart3200T Ultrasound System
K150533 · IYN
Teratech Corp.
Radiology · 68d