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"
553–576 of 681
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 02, 2009
ATRICURE CRYO1 CRYO-ABLATION PROBE
K082074 · GEH
AtriCure, Inc.
General & Plastic Surgery · 222d
Cleared Feb 20, 2009
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K090334 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 10d
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 11, 2009
COLON VIEW, MODEL CSCV-001A
K090220 · JAK
Toshibamedical Systems Corporation
Radiology · 13d
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 23, 2008
QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY
K083613 · GEX
Quanta System Spa
General & Plastic Surgery · 15d
Cleared Dec 12, 2008
MODEL TSX-301B AQUILION CT SYSTEM
K083282 · JAK
Toshiba America Medical Systems, In.C
Radiology · 35d
Cleared Dec 11, 2008
CHAPERON GUIDING CATHETER
K082385 · DQY
MicroVention, Inc.
Cardiovascular · 114d
Cleared Dec 04, 2008
HEADWAY 17 MICROCATHETER
K083343 · DQY
MicroVention, Inc.
Cardiovascular · 21d
Cleared Nov 14, 2008
ULTRAWAVE III EX 1320
K083207 · GEX
Quanta System Spa
General & Plastic Surgery · 14d
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 25, 2008
MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)
K081386 · IYN
Esaote, S.P.A.
Radiology · 129d
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 18, 2008
ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE
K082569 · EOB
Entellus Medical, Inc.
Ear, Nose, Throat · 13d