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"
1153–1176 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 17, 2005
FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A
K051500 · IYO
Toshiba America Medical Systems, In.C
Radiology · 10d
Cleared Jun 13, 2005
ATRICURE ISOLATOR TRANSPOLAR PEN
K050459 · OCL
AtriCure, Inc.
Cardiovascular · 110d
Cleared Jun 03, 2005
TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER
K051334 · IYN
Teratech Corp.
Radiology · 11d
Cleared Jun 03, 2005
ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM
K051304 · IYO
Science Surgical Corporation
Radiology · 15d
Cleared May 20, 2005
THE HERMES SYSTEM
K050929 · DRG
Palaistra Systems, Inc.
Cardiovascular · 36d
Cleared May 19, 2005
CARDIOSCOPE SONOPLUS 3000
K051126 · DPS
Pulsonic Ag, Medical Technology
Cardiovascular · 16d
Cleared May 13, 2005
ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
K051139 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 9d
Cleared Apr 29, 2005
MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS
K050950 · GEX
Active Optical Systems, Ltd./Efraim...
General & Plastic Surgery · 14d
Cleared Mar 24, 2005
MEGA POWER ELECTROSURGICAL GENERATOR
K050579 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 17d
Cleared Mar 22, 2005
VOYAGER PERSONAL IMAGING DEVICE
K050551 · IYO
Ardent Sound, Inc.
Radiology · 19d
Cleared Mar 10, 2005
TSX-201A AQUILION LB CT SCANNER
K050458 · JAK
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Mar 10, 2005
VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE
K042952 · LYZ
Zibo Hengchang Plastic & Rubber...
General Hospital · 135d
Cleared Mar 10, 2005
PRE-POWDERED VINYL EXAM GLOVES
K042951 · LYZ
Zibo Hengchang Plastic & Rubber...
General Hospital · 135d
Cleared Feb 25, 2005
MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM
K050347 · GEH
Endocare, Inc.
Radiology · 14d
Cleared Feb 23, 2005
XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A
K050380 · IYN
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Feb 15, 2005
MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM
K050240 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 13d
Cleared Feb 09, 2005
MULTIDIAGNOST ELEVA
K050151 · KPR
Philips Medical Systems North...
Radiology · 16d
Cleared Feb 01, 2005
E-Z PEN, REUSEABLE HANDSWITCHING PENCIL
K050102 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 14d
Cleared Jan 13, 2005
SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
K050034 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 6d
Cleared Jan 12, 2005
SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
K043559 · IYN
Sonosite,Inc.
Radiology · 16d
Cleared Dec 21, 2004
TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM
K043452 · IYN
Sonosite,Inc.
Radiology · 6d
Cleared Dec 15, 2004
VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM
K043333 · LLZ
Vital Images, Inc.
Radiology · 12d
Cleared Dec 13, 2004
TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES
K043278 · ITX
Teratech Corp.
Radiology · 17d
Cleared Nov 24, 2004
COMMANDER II
K043096 · DXN
Cardiocom
Cardiovascular · 15d