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"
385–408 of 681
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 04, 2016
Acclarix LX8 Diagnostic Ultrasound System
K160790 · IYN
Edan Instruments, Inc.
Radiology · 13d
Cleared Mar 22, 2016
cryoFORM cryoICE cryoablation probe
K152337 · GEH
AtriCure, Inc.
General & Plastic Surgery · 216d
Cleared Feb 19, 2016
I4 (Integrated Intelligent Imaging Informatics) system
K160315 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 14d
Cleared Feb 02, 2016
WS80A Diagnostic Ultrasound System
K153529 · IYN
Samsung Medison Co., Ltd.
Radiology · 55d
Cleared Dec 21, 2015
HM70A Diagnostic Ultrasound System
K153408 · IYN
Samsung Medison Co., Ltd.
Radiology · 26d
Cleared Nov 16, 2015
UroNav (Version 2.0)
K153073 · LLZ
Invivo Corporation
Radiology · 25d
Cleared Nov 02, 2015
HS70A Diagnostic Ultrasound System
K152962 · IYN
Samsung Medison Co., Ltd.
Radiology · 26d
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 02, 2015
DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems
K152545 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 24d
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 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 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 06, 2015
Acclarix Diagnostic Ultrasound System
K150999 · IYO
Edan Instruments, Inc.
Radiology · 21d
Cleared May 04, 2015
ERBECRYO 2 Cryosurgical Unit with accessories
K151041 · GEH
Erbe USA, Inc.
General & Plastic Surgery · 14d
Cleared Apr 16, 2015
Nitroglycerin Sets with DUO-VENT Spike
K150860 · FPA
Baxter Healthcare Corporation
General Hospital · 15d
Cleared Apr 10, 2015
DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems
K150204 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 71d
Cleared Mar 26, 2015
A35 Diagnostic Ultrasound System
K150478 · IYN
Samsung Medison Co., Ltd.
Radiology · 30d
Cleared Feb 20, 2015
U50 Diagnostic Ultrasound System
K142511 · IYN
Edan Instruments, Inc.
Radiology · 165d
Cleared Feb 09, 2015
ACUSON P500 Diagnostic Ultrasound System
K150050 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Feb 03, 2015
Infusion Aspiration Catheter System
K143563 · QEW
Inari Medical, Inc.
Cardiovascular · 49d
Cleared Jan 12, 2015
Presto Inflation Device
K143522 · MAV
C.R. Bard, Inc.
Cardiovascular · 31d
Cleared Jan 02, 2015
TE7 Diagnostic Ultrasound System
K143472 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 28d