FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

502 results for "Regulatory Technology Services, LLC"
409–432 of 502
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 13, 2010
VASCUTRAK PTA DILATATION CATHETER
K103459 · PNO
C.R. Bard, Inc.
Cardiovascular · 19d
Cleared Sep 22, 2010
ENSITE VERISMO SEGMENTATION TOOL V.2.0
K101697 · LLZ
St Jude Medical
Radiology · 98d
Cleared Sep 20, 2010
SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
K102017 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 63d
Cleared Jul 21, 2010
GLIDESHEATH
K102008 · DYB
Terumo Medical Corp.
Cardiovascular · 5d
Cleared Apr 28, 2010
ROLL-X GUIDEWIRE
K100710 · DQX
St Jude Medical
Cardiovascular · 47d
Cleared Mar 03, 2010
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K093812 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Feb 25, 2010
ENSITE VELOCITY SYSTEM V1.3
K093942 · DQK
St Jude Medical
Cardiovascular · 65d
Cleared Jan 28, 2010
MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM
K100067 · ITX
Toshiba America Medical Systems, In.C
Radiology · 17d
Cleared Dec 15, 2009
EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
K093583 · DQK
St Jude Medical
Cardiovascular · 26d
Cleared Dec 04, 2009
VIAMO SSA-640A VERSION 1.2
K093171 · IYN
Toshiba America Medical Systems, In.C
Radiology · 57d
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
Cleared Jul 29, 2009
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001
K092179 · IYN
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Jun 04, 2009
R2 DIGITALNOW HD(DIGITALNOW HD)
K091368 · LLZ
Hologic, Inc.
Radiology · 27d
Cleared May 15, 2009
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0
K091295 · ITX
Toshiba America Medical Systems, In.C
Radiology · 11d
Cleared May 15, 2009
SYNGO US WORKPLACE
K091286 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Apr 22, 2009
ULTIMUM/ENGAGE/ENGAGE TR
K091137 · DYB
St Jude Medical
Cardiovascular · 2d
Cleared Apr 15, 2009
TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
K082997 · FOZ
Terumo Medical Corp.
General Hospital · 189d
Cleared Feb 19, 2009
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
K090276 · DQO
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Feb 13, 2009
DRAD30003/RADREX-I
K083503 · KPR
Toshiba America Medical Systems, In.C
Radiology · 79d
Cleared Feb 06, 2009
APLIO ARTIDA V2.0 SSH-880CV
K090158 · IYN
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Feb 06, 2009
RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
K090040 · DQO
Terumo Medical Corp.
Cardiovascular · 31d
Cleared Jan 14, 2009
ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
K083149 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Dec 12, 2008
MODEL TSX-301B AQUILION CT SYSTEM
K083282 · JAK
Toshiba America Medical Systems, In.C
Radiology · 35d