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"
577–600 of 681
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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 12, 2008
CONTURA LUMEN MARKER
K082264 · JAQ
Senorx, Inc.
Radiology · 32d
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 Jul 11, 2008
CX50 DIAGNOSTIC ULTRASOUND SYSTEM
K081802 · ITX
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Jul 10, 2008
MODEL 7340 ULTRASOUND SYSTEM
K081794 · IYN
Esaote, S.P.A.
Radiology · 15d
Cleared Jun 24, 2008
HD15 DIAGNOSTIC ULTRASOUND SYSTEM
K081661 · IYN
Philips Ultrasound, Inc.
Radiology · 11d
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 17, 2008
DC NEURO
K081262 · LLZ
Invivo Corporation
Radiology · 43d
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 May 02, 2008
CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY
K081079 · JAQ
Senorx, Inc.
Radiology · 16d
Cleared Apr 30, 2008
CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS...
K080791 · JAQ
Senorx, Inc.
Radiology · 41d
Cleared Apr 17, 2008
TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
K080863 · DQX
MicroVention, Inc.
Cardiovascular · 20d
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 Mar 11, 2008
ATRICURE COOLRAIL LINEAR PEN
K073605 · OCL
AtriCure, Inc.
Cardiovascular · 81d
Cleared Feb 28, 2008
Q-PLUS T
K073549 · GEX
Quanta System Spa
General & Plastic Surgery · 72d
Cleared Feb 20, 2008
VITREA 4DCT
K072821 · LLZ
Vital Images, Inc.
Radiology · 141d