FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

1,198 results for "regulatory technology services, llc"
913–936 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 18, 2009
ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS
K083735 · JOM
Medtechs, LLC
Cardiovascular · 64d
Cleared Feb 13, 2009
AIRSTRIP OB
K090269 · HGM
Airstrip Technologies, LP
Obstetrics & Gynecology · 10d
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 Feb 06, 2009
MODEL PC-860 FETAL DOPPLER
K082055 · KNG
Shenzhen Creative Industry Co., Ltd.
Obstetrics & Gynecology · 200d
Cleared Feb 05, 2009
ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX
K083684 · KNT
Manufacturing & Research, Inc.
Gastroenterology & Urology · 55d
Cleared Jan 30, 2009
MYLABFIVE
K083882 · IYN
Esaote Europe B.V.
Radiology · 32d
Cleared Jan 23, 2009
AIRSTRIP OB
K090061 · HGM
Airstrip Technologies, LP
Obstetrics & Gynecology · 14d
Cleared Jan 14, 2009
ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
K083149 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Dec 30, 2008
MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL
K083765 · FPA
Medegen Medical Manufacturing Services
General Hospital · 12d
Cleared Dec 23, 2008
QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY
K083613 · GEX
Quanta System Spa
General & Plastic Surgery · 15d
Cleared Dec 23, 2008
TT1 GENERAL PURPOSE COIL
K083434 · MOS
Tursiop Technologies, LLC
Radiology · 33d
Cleared Dec 17, 2008
HEARTSUITE HEMODYNAMICS 7.10
K082421 · DQK
Emageon, Inc.
Cardiovascular · 117d
Cleared Dec 15, 2008
HEARTRAK SMART ECAT
K083535 · DXH
Universal Medical, Inc.
Cardiovascular · 17d
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 09, 2008
MEDEGEN PRESSURE RATED EXTENSION SETS
K083472 · FPA
Medegen, Inc.
General Hospital · 15d
Cleared Dec 04, 2008
HEADWAY 17 MICROCATHETER
K083343 · DQY
MicroVention, Inc.
Cardiovascular · 21d
Cleared Nov 26, 2008
CARDIO-VIEW
K083321 · DXJ
Curlview Igt, LLC
Cardiovascular · 15d
Cleared Nov 25, 2008
VIPERSPHERE PTA BALLOON CATHETER
K083139 · DQY
Cardiovascular Systems, Inc.
Cardiovascular · 33d
Cleared Nov 18, 2008
VIDA PULMONARY WORKSTATION 2 (PW2)
K083227 · JAK
Vida Diagnostics, Inc.
Radiology · 15d
Cleared Nov 14, 2008
ULTRAWAVE III EX 1320
K083207 · GEX
Quanta System Spa
General & Plastic Surgery · 14d