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"
1129–1152 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 15, 2005
VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE
K052632 · LLZ
Vital Images, Inc.
Radiology · 80d
Cleared Dec 07, 2005
EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)
K053281 · LLZ
Emageon, Inc.
Radiology · 12d
Cleared Nov 30, 2005
DATRIX CARDIO WIFI ELECTROCARDIOGRAPH
K053083 · DPS
Datrix
Cardiovascular · 28d
Cleared Nov 18, 2005
ENCOMPASS SOFTWARE PACKAGE
K053043 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 21d
Cleared Nov 16, 2005
SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
K053069 · IYN
Sonosite,Inc.
Radiology · 15d
Cleared Nov 02, 2005
Y2K2 ENTERNAL TUBE FLUID FILTER
K051206 · KNT
Moss Medical Products
Gastroenterology & Urology · 175d
Cleared Nov 01, 2005
CARDIOSERVER
K052883 · DQK
Datrix
Cardiovascular · 19d
Cleared Oct 27, 2005
FOURSIGHT VIEWTOOL IMAGE VIEWER
K052895 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 13d
Cleared Oct 26, 2005
MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR
K052884 · OWB
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Oct 25, 2005
ATRICURE TRANSPOLAR SYSTEM
K052893 · GEI
AtriCure, Inc.
General & Plastic Surgery · 11d
Cleared Sep 30, 2005
DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE
K052551 · FMF
Devon Safety Products, Inc.
General Hospital · 14d
Cleared Sep 28, 2005
FUSION CURING LIGHT
K052593 · EBZ
Dentlight, Inc.
Dental · 7d
Cleared Sep 27, 2005
PORTAL GRAVITY SYSTEM
K052579 · LNH
Portal, Inc.
Radiology · 7d
Cleared Sep 09, 2005
TRU-SWAB STOCOCK
K052330 · FMG
Medegen Medical Manufacturing Services
General Hospital · 14d
Cleared Aug 23, 2005
GAV - GENERAL ANAESTHETIC VAPORIZER
K051666 · CAD
General Anaesthetic Services Limited
Anesthesiology · 62d
Cleared Aug 19, 2005
TEM 3000 HEAD COIL
K052200 · MOS
Mr Instruments, Inc.
Radiology · 7d
Cleared Aug 16, 2005
DRUG ACCESS SPIKE
K051930 · FMF
Medegen Medical Manufacturing Services
General Hospital · 34d
Cleared Aug 15, 2005
ENSITE VERISMO SOFTWARE
K051840 · LLZ
St Jude Medical
Radiology · 39d
Cleared Aug 11, 2005
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES)
K052109 · IYN
Sonosite,Inc.
Radiology · 7d
Cleared Aug 01, 2005
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR
K051939 · FPA
Medegen Medical Manufacturing System
General Hospital · 14d
Cleared Jul 15, 2005
TSX-101A/H AQUILION 64 SP CT SCANNER
K051833 · JAK
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Jul 14, 2005
QD KNEE/FOOT COIL, MODEL MJQJ-147A
K051763 · MOS
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jul 08, 2005
THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT
K051668 · NUC
Goodmark USA, Inc.
Obstetrics & Gynecology · 16d
Cleared Jun 22, 2005
INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
K051499 · FPA
Medegen Medical Manufacturing Services
General Hospital · 15d