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

130 results for "Citech"
1–24 of 130
Search insights Median review: 17d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Radiology
Cleared May 22, 2026
Zenith Distal Access Long Sheath
K253359 · QJP
Suzhou Zenith Vascular SciTech Limited
Neurology · 234d
Cleared May 20, 2026
Zenith Aspiration Catheter
K252707 · NRY
Suzhou Zenith Vascular SciTech Limited
Neurology · 266d
Cleared Apr 16, 2026
Zenith Micro Guidewire
K252317 · MOF
Suzhou Zenith Vascular SciTech Limited
Neurology · 265d
Cleared Sep 29, 2025
Portable oxygen concentrator (JAY-1000P)
K243833 · CAW
Longfian Scitech Co., Ltd.
Anesthesiology · 290d
Cleared Jul 30, 2025
Micro Catheter
K243534 · KRA
Suzhou Zenith Vascular SciTech Limited
Neurology · 257d
Cleared Dec 08, 2022
Oxygen Concentrator, Model JAY-5AW
K213210 · CAW
Longfian Scitech Co., Ltd.
Anesthesiology · 435d
Cleared Sep 05, 2014
LONGFIAN OXYGEN CONCENTRATOR
K131968 · CAW
Longfian Scitech Co., Ltd.
Anesthesiology · 434d
Cleared May 12, 2010
GLIDER PTA BALLOON CATHETER
K101062 · LIT
Trireme Medical, Inc.
Cardiovascular · 26d
Cleared May 05, 2010
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K100830 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 42d
Cleared Apr 30, 2010
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
K101041 · ITX
Shenzhen Mindray Bio-Medical...
Radiology · 16d
Cleared Mar 05, 2010
SITE-RITE VISION ULTRASOUND SYSTEM
K100402 · IYN
Bard Access Systems, Inc.
Radiology · 17d
Cleared Nov 10, 2009
FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK,...
K093068 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 41d
Cleared Oct 15, 2009
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
K092691 · ITX
Shenzhen Mindray Bio-Medical...
Radiology · 43d
Cleared Jul 09, 2009
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K091941 · ITX
Shenzhen Mindray Bio-Medical...
Radiology · 9d
Cleared Apr 15, 2009
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900
K090912 · ITX
Shenzhen Mindray Bio-Medical...
Radiology · 14d
Cleared Apr 07, 2009
MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
K090087 · FRN
Iradimed Corporation
General Hospital · 84d
Cleared Dec 24, 2008
CONQUEST PTA BALLOON DILATATION CATHETER
K083657 · DQY
C.R. Bard, Inc.
Cardiovascular · 14d
Cleared Dec 12, 2008
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K083505 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 16d
Cleared Dec 03, 2008
VICARDIO 12B
K082380 · DPS
Energy-Lab Technologies GmbH
Cardiovascular · 106d
Cleared Nov 05, 2008
COMPONENT NEUROMONITORING SYSTEM
K080217 · OMA
Moberg Research, Inc.
Neurology · 281d
Cleared Oct 22, 2008
M5 DIAGNOSTIC ULTRASOUND SYSTEM
K083001 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 14d
Cleared Sep 09, 2008
UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM
K081919 · ITX
Fukuda Denshi Co., Ltd.
Radiology · 64d
Cleared May 27, 2008
DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K081320 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 15d
Cleared Mar 21, 2008
M5 DIAGNOSTIC ULTRASOUND SYSTEM
K080640 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 15d