FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

681 results for "regulatory technology services, llc"
361–384 of 681
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 14, 2017
Bard Mission Disposable Core Biopsy Instrument
K171953 · KNW
Bard Peripheral Vascular, Inc.
Gastroenterology & Urology · 77d
Cleared Aug 17, 2017
BD Intima II PLUS Closed IV Catheter System
K172204 · FOZ
Becton, Dickinson and Company
General Hospital · 27d
Cleared Aug 15, 2017
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic...
K172374 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 8d
Cleared Aug 08, 2017
HS40 Diagnostic Ultrasound System
K172129 · IYN
Samsung Medison Co., Ltd.
Radiology · 25d
Cleared Jul 12, 2017
Acuson SC2000 Diagnostic Ultrasound System
K171766 · IYO
Siemens Medi Cal Solutions, Inc.
Radiology · 28d
Cleared Apr 04, 2017
Acuson SC2000 Diagnostic Ultrasound System
K170315 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 62d
Cleared Mar 28, 2017
HS50 / HS60 Diagnostic Ultrasound System
K170493 · IYN
Samsung Medison Co., Ltd.
Radiology · 39d
Cleared Mar 10, 2017
BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless...
K170336 · FOZ
Becton, Dickinson and Company
General Hospital · 36d
Cleared Feb 28, 2017
BD Nexiva Diffusics Closed IV Catheter System
K170283 · FOZ
Becton, Dickinson and Company
General Hospital · 29d
Cleared Feb 22, 2017
HS70A Diagnostic Ultrasound System
K163691 · IYN
Samsung Medison Co., Ltd.
Radiology · 56d
Cleared Feb 16, 2017
ClotTriever Thrombectomy System
K163549 · QEW
Inari Medical, Inc.
Cardiovascular · 62d
Cleared Feb 06, 2017
3M Protemp Cement Temporary Dental Cement
K170330 · EMA
3M Company
Dental · 4d
Cleared Jan 04, 2017
ACUSON P500 Ultrasound System
K163396 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Nov 30, 2016
Solution Set for Epidural Use
K161323 · FPA
Baxter Healthcare Corporation
General Hospital · 203d
Cleared Nov 28, 2016
Filtek One Bulk Fill Restorative
K163207 · EBF
3M Company
Dental · 13d
Cleared Sep 28, 2016
Acuson Freestyle Ultrasound System
K162417 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 29d
Cleared Sep 14, 2016
dS FootAnkle I6CH 1.5T Coil
K162177 · MOS
Invivo Corporation
Radiology · 41d
Cleared Sep 06, 2016
ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System
K162243 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 27d
Cleared Aug 31, 2016
1.5T and 3.0T 16 CH GE Shoulder Coils
K162001 · MOS
Invivo Corporation
Radiology · 42d
Cleared Aug 29, 2016
BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
K161777 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 61d
Cleared Aug 26, 2016
RS80A Diagnostic Ultrasound System
K162094 · IYN
Samsung Medison Co., Ltd.
Radiology · 29d
Cleared Aug 10, 2016
5D Viewer
K161955 · LLZ
Samsung Medison Co., Ltd.
Radiology · 23d
Cleared Jul 28, 2016
ACUSON NX2 Diagnostic Ultrasound Systems
K161787 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Jun 03, 2016
Halo One Thin-Walled Guiding Sheath
K161183 · DYB
C.R. Bard, Inc.
Cardiovascular · 37d