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

750 results for "Regulatory Technology Services, LLC"
553–576 of 750
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 21, 2010
GLIDESHEATH
K102008 · DYB
Terumo Medical Corp.
Cardiovascular · 5d
Cleared Jul 19, 2010
EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM
K101455 · IYN
Medison Co., Ltd.
Radiology · 55d
Cleared Jul 16, 2010
THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM
K101829 · ITX
Medison Co., Ltd.
Radiology · 15d
Cleared Jun 03, 2010
BD INTIMA II CLOSED IV CATHETER
K100775 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 77d
Cleared May 14, 2010
MRI PATIENT POSITIONING DEVICES
K093738 · LNH
Medtec, Inc.
Radiology · 161d
Cleared Apr 28, 2010
ROLL-X GUIDEWIRE
K100710 · DQX
St Jude Medical
Cardiovascular · 47d
Cleared Mar 24, 2010
MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM
K100186 · IYN
Medison Co., Ltd.
Radiology · 61d
Cleared Mar 17, 2010
MODEL VISULAS 532S LASER WITH THE VITE OPTION
K100035 · GEX
Carl Zeiss Meditec, AG
General & Plastic Surgery · 70d
Cleared Mar 03, 2010
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K093812 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Feb 26, 2010
TRAILRUNNER GUIDEWIRES
K092965 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 154d
Cleared Feb 25, 2010
ENSITE VELOCITY SYSTEM V1.3
K093942 · DQK
St Jude Medical
Cardiovascular · 65d
Cleared Feb 01, 2010
IU22 ULTRASOUND SYSTEM AND TRANSDUCERS
K093563 · IYN
Philips Ultrasound, Inc.
Radiology · 75d
Cleared Jan 28, 2010
MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM
K100067 · ITX
Toshiba America Medical Systems, In.C
Radiology · 17d
Cleared Jan 19, 2010
ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
K093849 · IYN
Medison Co., Ltd.
Radiology · 34d
Cleared Dec 15, 2009
EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
K093583 · DQK
St Jude Medical
Cardiovascular · 26d
Cleared Dec 10, 2009
SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
K093714 · ITX
Medison Co., Ltd.
Radiology · 8d
Cleared Dec 04, 2009
VIAMO SSA-640A VERSION 1.2
K093171 · IYN
Toshiba America Medical Systems, In.C
Radiology · 57d
Cleared Dec 01, 2009
ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM
K093531 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 15d
Cleared Nov 20, 2009
ENCOR BREAST BIOPSY SYSTEM
K093512 · KNW
Senorx, Inc.
Gastroenterology & Urology · 7d
Cleared Nov 06, 2009
ASEPT PLEURAL DRAINAGE SYSTEM
K093307 · DWM
Pfm Medical, Inc.
Anesthesiology · 15d
Cleared Nov 06, 2009
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
K093301 · MCW
Ev3, Inc.
Cardiovascular · 16d
Cleared Nov 06, 2009
DX-D IMAGING PACKAGE
K092669 · MQB
Agfa Healthcare N.V.
Radiology · 67d
Cleared Oct 09, 2009
APLIO MX SSA-780A, VERSION 1.0
K092948 · IYN
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Oct 08, 2009
ENGAGE/ENGAGE TR
K092575 · DYB
St Jude Medical
Cardiovascular · 48d