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"
529–552 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 16, 2014
ArthroPlan Digital Templating Software
K142944 · LLZ
Arthromeda, Inc.
Radiology · 67d
Cleared Dec 10, 2014
eSie Apps Suite
K143254 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 10, 2014
DISTAL ACCESS TORQUE DEVICE
K141054 · DQX
Distal Access, LLC
Cardiovascular · 236d
Cleared Dec 09, 2014
H60 V2.00 Diagnostic Ultrasound System
K143264 · IYN
Samsung Medison Co., Ltd.
Radiology · 26d
Cleared Dec 04, 2014
NATURE'S BOND 600 AND NATURE'S BOND 603
K142168 · HGX
Devon Medical Products, Inc.
Obstetrics & Gynecology · 120d
Cleared Nov 26, 2014
WS80A Diagnostic Ultrasound System
K143089 · IYN
Samsung Medison Co., Ltd.
Radiology · 29d
Cleared Nov 20, 2014
MaxZero Administration Sets
K143234 · FPA
Care Fusion
General Hospital · 10d
Cleared Oct 29, 2014
Leo Minor
K142984 · FSY
Sunnex, Inc.
General & Plastic Surgery · 13d
Cleared Oct 28, 2014
Fortrex 0.035 OTW PTA Balloon Catheter
K142654 · LIT
Covidien, LLC
Cardiovascular · 40d
Cleared Oct 24, 2014
OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS
K141759 · MMK
Oak Ridge Products, LLC
General Hospital · 115d
Cleared Oct 23, 2014
ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems
K142876 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Oct 10, 2014
Acuson SC2000 Diagnostic Ultrasound System
K142628 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 24d
Cleared Oct 07, 2014
SIMPLY SLICK PERSONAL LUBRICATING LOTION
K140304 · NUC
Simply Solutions, LLC
Obstetrics & Gynecology · 242d
Cleared Oct 03, 2014
UGEO PT60A Diagnostic Ultrasound System
K142466 · IYN
Samsung Medison Co., Ltd.
Radiology · 31d
Cleared Sep 24, 2014
Ultraverse 035 PTA Balloon Dilatation Catheter
K142261 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 41d
Cleared Sep 19, 2014
Extension Set with BD Q-Syte Luer Access Split Septum
K142527 · FPA
Acacia, Inc.
General Hospital · 11d
Cleared Sep 12, 2014
WHISPERJECT AUTOINJECTOR
K141384 · KZH
Scandinavian Health Limited
General Hospital · 108d
Cleared Sep 09, 2014
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
K142395 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 13d
Cleared Sep 09, 2014
ECARE COORDINATOR (ECC)
K141706 · DRG
Visicu, Inc.
Cardiovascular · 77d
Cleared Sep 03, 2014
VITALOGRAPH MODEL 7000 SPIROTRAC
K141546 · BZG
Vitalograph (Ireland) , Ltd.
Anesthesiology · 85d
Cleared Aug 26, 2014
VERITRACT ENTERAL FEEDING TUBE SYSTEM
K133334 · KNT
Veritract, Inc.
Gastroenterology & Urology · 301d
Cleared Aug 22, 2014
X-PORTE ULTRASOUND SYSTEM
K142017 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 28d
Cleared Aug 14, 2014
WHITNEY MEDICAL SOLUTIONS ESHIELD
K141438 · KKX
Whitney Medical Solutions
General Hospital · 76d
Cleared Aug 07, 2014
BREAST VOLUME NAVIGATOR
K141870 · IYN
Metritrack, LLC
Radiology · 27d