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"
505–528 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 06, 2015
Acclarix Diagnostic Ultrasound System
K150999 · IYO
Edan Instruments, Inc.
Radiology · 21d
Cleared May 04, 2015
ERBECRYO 2 Cryosurgical Unit with accessories
K151041 · GEH
Erbe USA, Inc.
General & Plastic Surgery · 14d
Cleared Apr 30, 2015
Vitaphone Tele ECG Loop Recorder
K151013 · DXH
Vitasystems GmbH
Cardiovascular · 15d
Cleared Apr 23, 2015
NICO TRIOwand
K150993 · GEI
Nico Corporation
General & Plastic Surgery · 8d
Cleared Apr 16, 2015
Nitroglycerin Sets with DUO-VENT Spike
K150860 · FPA
Baxter Healthcare Corporation
General Hospital · 15d
Cleared Apr 16, 2015
Alcyone MEMS Cannula (AMC) System
K150660 · HCD
Alcyone Lifesciences, Inc.
Neurology · 34d
Cleared Apr 10, 2015
DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems
K150204 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 71d
Cleared Apr 07, 2015
UltraVision 2 Diagnostic Ultrasound System
K150580 · IYO
Winprobe Corporation
Radiology · 29d
Cleared Apr 02, 2015
AWARE
K143372 · MWI
Ambient Clinical Analytics
Cardiovascular · 128d
Cleared Mar 26, 2015
A35 Diagnostic Ultrasound System
K150478 · IYN
Samsung Medison Co., Ltd.
Radiology · 30d
Cleared Mar 09, 2015
Schoelly Cystoscopes/Hysteroscopes and Accessories
K150158 · HIH
Schoelly Fiberoptic GmbH
Obstetrics & Gynecology · 45d
Cleared Mar 04, 2015
ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System
K150249 · IYN
Zonare Medical Systems, Inc.
Radiology · 29d
Cleared Feb 24, 2015
Synergetics PHOTON EX
K143123 · MPA
Synergetics
Ophthalmic · 116d
Cleared Feb 20, 2015
Terason uSmart3300 Ultrasound System
K150148 · IYN
Teratech Corp.
Radiology · 28d
Cleared Feb 20, 2015
U50 Diagnostic Ultrasound System
K142511 · IYN
Edan Instruments, Inc.
Radiology · 165d
Cleared Feb 09, 2015
ACUSON P500 Diagnostic Ultrasound System
K150050 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Feb 03, 2015
Infusion Aspiration Catheter System
K143563 · QEW
Inari Medical, Inc.
Cardiovascular · 49d
Cleared Jan 23, 2015
Visi Mobile Monitoring System
K143751 · MWI
Sotera Wireless, Inc.
Cardiovascular · 23d
Cleared Jan 21, 2015
ECHO TRUE 3D VIEWER
K142107 · LLZ
Echopixel, Inc.
Radiology · 173d
Cleared Jan 14, 2015
SignosRT Bladder Ultrasound System
K143493 · IYO
Signostics, Ltd.
Radiology · 36d
Cleared Jan 12, 2015
Surefire Infusion System 021
K143588 · DQO
Surefire Medical, Inc.
Cardiovascular · 25d
Cleared Jan 12, 2015
Presto Inflation Device
K143522 · MAV
C.R. Bard, Inc.
Cardiovascular · 31d
Cleared Jan 08, 2015
ANUTRA Feedback Aspiration Syringe
K143757 · FMF
Anutra Medical, Inc.
General Hospital · 8d
Cleared Jan 02, 2015
TE7 Diagnostic Ultrasound System
K143472 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 28d