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"
1009–1032 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 08, 2008
TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041
K073366 · FLL
Shenzhen Dongdixin Technology Co., Ltd.
General Hospital · 70d
Cleared Jan 23, 2008
VASCUVIEW ULTRASOUND SYSTEM
K080049 · IYO
Escalon Medical Corp.
Radiology · 15d
Cleared Jan 22, 2008
VANTAGE TITAN, MODEL MRT-1504/S3
K080038 · LNH
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Jan 17, 2008
REGISTRATION AND FUSION
K080013 · LLZ
Agfa Healthcare Corporation
Radiology · 14d
Cleared Jan 10, 2008
PC-180 / PRINCE 180 EASY ECG MONITOR
K073152 · DSH
Shenzhen Creative Industry Co., Ltd.
Cardiovascular · 63d
Cleared Jan 02, 2008
MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP
K073313 · GEX
Omniguide, Inc.
General & Plastic Surgery · 37d
Cleared Dec 20, 2007
XIDF-100A/B1 IMAGE PROCESSOR
K073259 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 30d
Cleared Dec 14, 2007
OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM
K073409 · GEX
Omniguide, Inc.
General & Plastic Surgery · 10d
Cleared Dec 07, 2007
ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)
K073372 · DXJ
Systemsone
Cardiovascular · 4d
Cleared Dec 07, 2007
DO-ALL DENTAL HANDPIECE LUBRICANT
K073353 · EFB
Prodrive Systems, Inc.
Dental · 8d
Cleared Dec 05, 2007
ORTHOGON
K073271 · LLZ
Agfa Healthcare Corporation
Radiology · 14d
Cleared Nov 29, 2007
SA-3000P
K073323 · JOM
Medicore Co., Ltd.
Cardiovascular · 2d
Cleared Nov 27, 2007
MODELS EMS 5.0, EMS 5.1
K072795 · IPF
Koalaty Products, Inc.
Physical Medicine · 57d
Cleared Nov 21, 2007
JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X
K073081 · LNH
Toshiba America Medical Systems, In.C
Radiology · 20d
Cleared Nov 21, 2007
CTU676 DEVICE
K073013 · JOW
Compression Technologies Unlimited, Inc.
Cardiovascular · 27d
Cleared Nov 19, 2007
SMARTSPONGE PLUS SYSTEM
K073180 · LWH
Clearcount Medical Solutions, Inc.
General & Plastic Surgery · 6d
Cleared Nov 16, 2007
DRAD-3000E, RADREX-I
K073165 · MQB
Toshiba America Medical Systems, In.C
Radiology · 7d
Cleared Nov 16, 2007
COLLIMARE COLLIMATOR FAMILY
K073124 · IZW
Collimare, LLC
Radiology · 10d
Cleared Nov 13, 2007
ACUSON S2000 ULTRASOUND SYSTEM
K072786 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 43d
Cleared Nov 06, 2007
MEDSTREAMING MEDICAL OFFICE SOFTWARE
K072972 · LLZ
Medstreaming, LLC
Radiology · 15d
Cleared Nov 01, 2007
CSNP-001A NEURO PACKAGE
K072693 · JAK
Toshiba America Medical Systems, In.C
Radiology · 38d
Cleared Oct 31, 2007
SPEEDER 1.5T WRIST ARRAY COIL
K072935 · MOS
Quality Electrodynamics
Radiology · 14d
Cleared Oct 30, 2007
MC 3003G-32R HEAD COIL
K072931 · MOS
Mr Instruments, Inc.
Radiology · 14d
Cleared Oct 29, 2007
MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00
K072918 · ITX
Toshibamedical Systems Corporation
Radiology · 14d