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"
1057–1080 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 29, 2007
A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
K063526 · CAH
A-M Systems, Inc.
General Hospital · 219d
Cleared Jun 05, 2007
UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
K071462 · ETW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 11d
Cleared May 30, 2007
VITAL CONNECT 4.1
K071362 · LLZ
Vital Images, Inc.
Radiology · 15d
Cleared May 25, 2007
VITREA VERSION 4.0
K071331 · LLZ
Vital Images, Inc.
Radiology · 14d
Cleared May 24, 2007
ANTLIA I WOUND IRRIGATION SYSTEM
K071301 · OMP
Innovative Therapies, Inc.
General & Plastic Surgery · 15d
Cleared May 22, 2007
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
K071314 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 12d
Cleared May 18, 2007
SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY
K071229 · JAQ
Senorx, Inc.
Radiology · 15d
Cleared May 08, 2007
AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS
K071162 · MQB
Agfa Healthcare Corp.
Radiology · 12d
Cleared May 08, 2007
SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM
K071134 · IYO
Sonosite,Inc.
Radiology · 15d
Cleared Apr 24, 2007
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261
K070311 · GEI
Medtronic Vascular
General & Plastic Surgery · 82d
Cleared Apr 17, 2007
INTERSON USB ULTRASOUND PROBE SYSTEM
K070907 · IYO
Regulatory Management Services
Radiology · 15d
Cleared Apr 13, 2007
ANTLIA II SUCTION PUMP SYSTEM
K070904 · OMP
Innovative Therapies, Inc.
General & Plastic Surgery · 11d
Cleared Apr 10, 2007
ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
K070813 · IYN
Medison Co., Ltd.
Radiology · 15d
Cleared Apr 06, 2007
QLAB QUANTIFICATION
K070792 · LLZ
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Mar 08, 2007
LIV BREAST SELF EXAMINATION AID
K070344 · IZH
Liv International USA, Inc.
Radiology · 30d
Cleared Feb 28, 2007
AMPLATZER RELIANT CATHETER DELIVERY SYSTEM
K070238 · DQY
Aga Medical Corp.
Cardiovascular · 34d
Cleared Feb 01, 2007
OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER
K070157 · GEX
Omniguide, Inc.
General & Plastic Surgery · 15d
Cleared Jan 26, 2007
ATRICURE ABLATION SYSTEM
K063630 · GEI
AtriCure, Inc.
General & Plastic Surgery · 51d
Cleared Jan 25, 2007
OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER
K070071 · GEX
Omniguide, Inc.
General & Plastic Surgery · 17d
Cleared Jan 05, 2007
ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
K063803 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 14d
Cleared Jan 04, 2007
ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM
K063761 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Jan 04, 2007
ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
K063559 · LNH
Philips Medical Systems
Radiology · 38d
Cleared Dec 19, 2006
MODEL 2200
K062635 · ILY
Clarimedex, Inc.
Physical Medicine · 104d
Cleared Dec 14, 2006
SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
K063580 · IYN
Medison Co., Ltd.
Radiology · 14d