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"
889–912 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 05, 2009
LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
K091160 · LLZ
Broncus Technologies, Inc.
Radiology · 14d
Cleared May 01, 2009
TXRX 1.5T CP HEAD COIL
K091114 · MOS
Quality Electrodynamics
Radiology · 14d
Cleared Apr 28, 2009
MPS ACACIA POWER INJECTABLE INFUSION SET
K090809 · FPA
Mps Acacia
General Hospital · 34d
Cleared Apr 22, 2009
ULTIMUM/ENGAGE/ENGAGE TR
K091137 · DYB
St Jude Medical
Cardiovascular · 2d
Cleared Apr 15, 2009
TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
K082997 · FOZ
Terumo Medical Corp.
General Hospital · 189d
Cleared Apr 14, 2009
BLUESHINE GOLD SERIES
K090297 · GEX
Blueshine Srl
General & Plastic Surgery · 67d
Cleared Apr 10, 2009
I OPEN 0.5T
K090873 · LNH
Beijing Wandong Medical Equipment...
Radiology · 10d
Cleared Apr 08, 2009
DIGDOP ULTRASOUND SYSTEM
K090465 · ITX
The Newman Group, LLC
Radiology · 44d
Cleared Apr 07, 2009
YIELD TISSUE SAMPLER
K090853 · EOQ
Broncus Technologies, Inc.
Ear, Nose, Throat · 8d
Cleared Apr 03, 2009
YIELD MINI DOPPLER SYSTEM
K090743 · IYN
Broncus Technologies, Inc.
Radiology · 14d
Cleared Apr 01, 2009
BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM
K090759 · JCX
Biodrain Medical, Inc.
General & Plastic Surgery · 9d
Cleared Mar 27, 2009
VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE
K090649 · LLZ
Virtual Radiologic Corporation
Radiology · 16d
Cleared Mar 25, 2009
FORUM
K090439 · NFJ
Carl Zeiss Meditec, Inc.
Ophthalmic · 33d
Cleared Mar 25, 2009
I_OPEN 0.4T
K090433 · LNH
Beijing Wandong Medical Equipment...
Radiology · 34d
Cleared Mar 24, 2009
WIRELESS PORTABLE DETECTOR FD-W17
K090625 · MQB
Philips Medical Systems North America...
Radiology · 15d
Cleared Mar 23, 2009
DEVON ACCUBP CUFF
K090664 · DXQ
Devon Medical, Inc.
Cardiovascular · 10d
Cleared Mar 16, 2009
VERADIUS, MODEL 718-130
K090590 · OWB
Philips Medical Systems North America...
Radiology · 12d
Cleared Mar 13, 2009
LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
K090095 · LLZ
Broncus Technologies, Inc.
Radiology · 57d
Cleared Mar 05, 2009
CSBP-001A BODY PERFUSION SYSTEM
K090504 · JAK
Toshibamedical Systems Corporation
Radiology · 7d
Cleared Mar 02, 2009
ATRICURE CRYO1 CRYO-ABLATION PROBE
K082074 · GEH
AtriCure, Inc.
General & Plastic Surgery · 222d
Cleared Feb 27, 2009
PRODRIVE LINE OF DENTAL HANDPIECES
K090369 · EFB
Prodrive Systems, Inc.
Dental · 14d
Cleared Feb 26, 2009
DX6605E-TENS, DX6605E-G, DX6609-G
K082057 · GZJ
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 220d
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