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"
841–864 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 10, 2009
SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
K093714 · ITX
Medison Co., Ltd.
Radiology · 8d
Cleared Dec 04, 2009
VIAMO SSA-640A VERSION 1.2
K093171 · IYN
Toshiba America Medical Systems, In.C
Radiology · 57d
Cleared Dec 01, 2009
ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM
K093531 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 15d
Cleared Nov 24, 2009
AXS-590 SERIES
K091650 · CAW
Swr International, Ltd.
Anesthesiology · 168d
Cleared Nov 20, 2009
ENCOR BREAST BIOPSY SYSTEM
K093512 · KNW
Senorx, Inc.
Gastroenterology & Urology · 7d
Cleared Nov 13, 2009
ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX...
K092619 · IYO
Civco
Radiology · 79d
Cleared Nov 12, 2009
SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED...
K093169 · FYA
A Plus International, Inc.
General Hospital · 36d
Cleared Nov 06, 2009
ASEPT PLEURAL DRAINAGE SYSTEM
K093307 · DWM
Pfm Medical, Inc.
Anesthesiology · 15d
Cleared Nov 06, 2009
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
K093301 · MCW
Ev3, Inc.
Cardiovascular · 16d
Cleared Nov 06, 2009
DX-D IMAGING PACKAGE
K092669 · MQB
Agfa Healthcare N.V.
Radiology · 67d
Cleared Oct 27, 2009
ACACIA PISTON SYRINGE
K092986 · FMF
Acacia, Inc.
General Hospital · 29d
Cleared Oct 15, 2009
TANDA RESTORE, MODEL PTSCS
K090008 · ILY
Pharos Life Corporation
Physical Medicine · 286d
Cleared Oct 09, 2009
APLIO MX SSA-780A, VERSION 1.0
K092948 · IYN
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Oct 08, 2009
ENGAGE/ENGAGE TR
K092575 · DYB
St Jude Medical
Cardiovascular · 48d
Cleared Oct 08, 2009
SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
K092014 · DYB
Onset Medical Corporation
Cardiovascular · 94d
Cleared Oct 02, 2009
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM
K092058 · IYN
Sonosite,Inc.
Radiology · 86d
Cleared Sep 18, 2009
ABVS WORKPLACE
K092067 · LLZ
Siemens AG Medical Solutions
Radiology · 71d
Cleared Sep 15, 2009
STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS)
K092134 · LLZ
Statrad, LLC
Radiology · 62d
Cleared Sep 11, 2009
HEARTRAIL III GUIDING CATHETER
K092372 · DQO
Terumo Corp.
Cardiovascular · 37d
Cleared Aug 27, 2009
DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540
K092537 · MUH
Toshiba America Electronic...
Radiology · 8d
Cleared Aug 19, 2009
CONTURA CAVITY MAINTENANCE CATHETER
K092323 · JAQ
Senorx, Inc.
Radiology · 15d
Cleared Aug 11, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
K092238 · MQB
Agfa Healthcare N.V.
Radiology · 19d
Cleared Aug 07, 2009
TRAILBLAZER SUPPORT CATHETER
K092299 · DQY
Ev3, Inc.
Cardiovascular · 9d
Cleared Aug 07, 2009
PHARMAPAC PERSONAL LUBRICANT
K091554 · NUC
Pharmapac, LLC
Obstetrics & Gynecology · 72d