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"
433–456 of 502
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 06, 2008
AGILIS NXT STEERABLE INTRODUCER
K083083 · DYB
St Jude Medical
Cardiovascular · 21d
Cleared Oct 17, 2008
ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
K083014 · MOS
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Oct 17, 2008
P3T ABDOMEN
K082458 · JAK
Medrad, Inc.
Radiology · 52d
Cleared Oct 14, 2008
4D VIEWER RADIOLOGY, MODEL USWP-100A
K082684 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 29d
Cleared Oct 10, 2008
INFX-8000H, INFINIX-I
K082830 · JAA
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Sep 26, 2008
FINECROSS MG CORONARY MICRO-GUIDE CATHETER
K082519 · KRA
Terumo Medical Corp.
Cardiovascular · 24d
Cleared Sep 24, 2008
RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
K082736 · DQO
Terumo Medical Corp.
Cardiovascular · 6d
Cleared Sep 23, 2008
ULTRAEXTEND USWS-900A
K082596 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Sep 18, 2008
GLIDESHEATH
K082644 · DYB
Terumo Medical Corp.
Cardiovascular · 7d
Cleared Sep 17, 2008
SURSHIELD SAFETY I.V. CATHETER
K082362 · FOZ
Terumo Medical Corp.
General Hospital · 30d
Cleared Sep 12, 2008
DRAD3000E/RADREX-I
K082494 · MQB
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Sep 12, 2008
QUANTRA
K082483 · LLZ
Hologic, Inc.
Radiology · 15d
Cleared Sep 11, 2008
ENSITE FUSION DYNAMIC REGISTRATION TOOL
K082467 · DQK
St Jude Medical
Cardiovascular · 15d
Cleared Aug 27, 2008
ROLL-X GUIDEWIRE
K082304 · DQX
St Jude Medical
Cardiovascular · 14d
Cleared Aug 21, 2008
PCA-8000A, MARK 11, PET / CT SYSTEM
K082244 · KPS
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Aug 12, 2008
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0
K082119 · IYN
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Jun 23, 2008
INFX-8000F (INFINIX CSI AND INFINIX DPI)
K081624 · MQB
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Jun 23, 2008
INFX-8000C (INFINIX CC-I AND VC-I)
K081621 · JAA
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jun 17, 2008
INFX-8000V, INFINIX-CFI AND INFINIX VFI
K081582 · JAA
Toshiba America Medical Systems, In.C
Radiology · 12d
Cleared Jun 11, 2008
CSBP-001A BODY ORGAN PERFUSION SYSTEM
K081482 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jun 06, 2008
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2
K081065 · IYN
Toshiba America Medical Systems, In.C
Radiology · 52d
Cleared Mar 14, 2008
MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM
K080211 · JAK
Toshiba America Medical Systems, In.C
Radiology · 45d
Cleared Feb 08, 2008
APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM
K080160 · IYN
Toshiba America Medical Systems, In.C
Radiology · 16d
Cleared Jan 22, 2008
VANTAGE TITAN, MODEL MRT-1504/S3
K080038 · LNH
Toshiba America Medical Systems, In.C
Radiology · 15d