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"
793–816 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 22, 2010
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
K102391 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 121d
Cleared Dec 13, 2010
VASCUTRAK PTA DILATATION CATHETER
K103459 · PNO
C.R. Bard, Inc.
Cardiovascular · 19d
Cleared Dec 10, 2010
QUANTA CYBER TM 150W
K102749 · GEX
Quanta System Spa
General & Plastic Surgery · 78d
Cleared Dec 08, 2010
SEEKER CROSSING SUPPORT CATHETER
K103367 · DQY
Bard Peripheral Vascular, Inc.
Cardiovascular · 22d
Cleared Dec 06, 2010
EVERCROSS 0.035 OTW PTA DILATION CATHETER
K103322 · LIT
Ev3, Inc.
Cardiovascular · 24d
Cleared Nov 19, 2010
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM
K102390 · IYN
Sonosite,Inc.
Radiology · 88d
Cleared Nov 19, 2010
PENRITH ELETTRA ULTRASOUND SYSTEM
K100598 · IYN
Penrith Corporation
Radiology · 261d
Cleared Nov 15, 2010
CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT
K103215 · JAQ
Cianna Medical
Radiology · 14d
Cleared Oct 29, 2010
DX-D 300
K103050 · KPR
Agfa Healthcare N.V.
Radiology · 14d
Cleared Oct 29, 2010
BLADEVIEW
K101042 · KPR
Accogent, LLC
Radiology · 198d
Cleared Oct 05, 2010
GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND
K102256 · IYN
Ge Medical Systems China Co., Ltd.
Radiology · 56d
Cleared Sep 23, 2010
NEOWIRE PTA/PTCA GUIDEWIRE
K101729 · DQX
Neometrics, Inc.
Cardiovascular · 94d
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 Aug 31, 2010
MYLABONE ULTRASOUND SYSTEM
K101605 · IYN
Esaote Europe B.V.
Radiology · 84d
Cleared Aug 17, 2010
REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR)
K101241 · NUC
Lil Drug Store Products, Inc.
Obstetrics & Gynecology · 105d
Cleared Aug 12, 2010
GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND
K102113 · IYN
Ge Medical Systems China Co., Ltd.
Radiology · 15d
Cleared Aug 12, 2010
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND...
K101757 · ITX
Sonosite,Inc.
Radiology · 50d
Cleared Aug 09, 2010
ALLURA XPER OR TABLE SERIES
K102005 · OWB
Philips Medical Systems North...
Radiology · 25d
Cleared Aug 06, 2010
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
K102065 · IYN
Medison Co., Ltd.
Radiology · 14d
Cleared Aug 06, 2010
HEADWAY 17 ADVANCED MICROCATHETER
K101542 · DQY
MicroVention, Inc.
Cardiovascular · 64d
Cleared Jul 22, 2010
QUANTA DIODE LASER SYSTEM
K100558 · GEX
Quanta System Spa
General & Plastic Surgery · 143d
Cleared Jul 21, 2010
GLIDESHEATH
K102008 · DYB
Terumo Medical Corp.
Cardiovascular · 5d
Cleared Jul 19, 2010
EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM
K101455 · IYN
Medison Co., Ltd.
Radiology · 55d