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"
1033–1056 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 26, 2007
BEMITT, MODEL 0001
K071787 · IZH
Dja Distributors, LLC
Radiology · 116d
Cleared Oct 24, 2007
APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM
K072826 · ITX
Toshiba America Medical Systems, In.C
Radiology · 21d
Cleared Oct 17, 2007
SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM
K072365 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 55d
Cleared Oct 05, 2007
CSCS-001A CALCIUM SCORING PACKAGE
K072737 · JAK
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Oct 05, 2007
VAX-D GENESIS G2 SYSTEM
K071347 · ITH
Vax-D Medical Technologies, LLC
Physical Medicine · 144d
Cleared Oct 04, 2007
POWRSYRINGE ASPIRATOR
K072299 · FMF
Pinyons Medical Technology, Inc.
General Hospital · 48d
Cleared Oct 02, 2007
AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM
K072606 · JAK
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Sep 25, 2007
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR
K072542 · FPA
Medegen Medical Manufacturing System
General Hospital · 15d
Cleared Sep 25, 2007
SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM
K072541 · ITX
Senorx, Inc.
Radiology · 15d
Cleared Sep 21, 2007
VISULAS TRION
K072514 · GEX
Carl Zeiss Meditec, AG
General & Plastic Surgery · 14d
Cleared Sep 21, 2007
POWRSYRINGE MONITOR
K072345 · FMF
Pinyons Medical Technology, Inc.
General Hospital · 31d
Cleared Sep 21, 2007
POWRSYRINGE INJECTOR
K072318 · FMF
Pinyons Medical Technology, Inc.
General Hospital · 32d
Cleared Sep 20, 2007
DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30
K072034 · GEX
Quanta System Spa
General & Plastic Surgery · 57d
Cleared Sep 13, 2007
BRK TRANSSEPTAL NEEDLE
K072278 · DRC
St Jude Medical
Cardiovascular · 28d
Cleared Aug 31, 2007
PHARMAPAC LUBRICATING JELLY
K070623 · NUC
Pharmapac, LLC
Obstetrics & Gynecology · 178d
Cleared Aug 30, 2007
MODIFICATION TO EZ HUBER SAFETY INFUSION SET
K071846 · FPA
Pfm Medical, Inc.
General Hospital · 56d
Cleared Aug 29, 2007
ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM
K072266 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Aug 15, 2007
ICATH, STERILESURE
K071496 · NWO
Colorado Catheter Company, Inc.
Gastroenterology & Urology · 76d
Cleared Aug 03, 2007
MYLAB30, MODEL 7300
K071996 · IYO
Esaote, S.P.A.
Radiology · 8d
Cleared Jul 30, 2007
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0
K072000 · IYN
Toshiba America Medical Systems, In.C
Radiology · 7d
Cleared Jul 30, 2007
ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS
K071972 · LLZ
Agfa Healthcare Corp.
Radiology · 13d
Cleared Jul 23, 2007
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP -...
K071847 · MOS
Shanghai Chenguang Medical...
Radiology · 18d
Cleared Jul 18, 2007
MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH,
K071882 · MOS
Shanghai Chenguang Medical...
Radiology · 9d
Cleared Jul 11, 2007
BACKPACK MEDICAL OXYGEN SYSTEM
K071581 · BYJ
Essex Cryogenics of Missouri, Inc.
Anesthesiology · 33d