FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

1,163 results for "shenzhen"
745–768 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Jun 22, 2020
Air Compression Therapy System
K192466 · IRP
Shenzhen Lifotronic Technology Co., Ltd.
Physical Medicine · 287d
Cleared Jun 22, 2020
Patient Monitoring Cable (SpO2 Extension Cable)
K192404 · DSA
Shenzhen Coreray Technology, Ltd.
Anesthesiology · 293d
Cleared Jun 18, 2020
TENS and Muscle Stimulator
K200727 · NUH
Shenzhen Astec Technology Co., Ltd.
Neurology · 90d
Cleared Jun 17, 2020
Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503
K193253 · FLL
Shenzhen Changkun Technology Co., Ltd.
General Hospital · 212d
Cleared Jun 08, 2020
ePM Series Patient monitors
K200015 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 157d
Cleared Jun 08, 2020
Air Compression Therapy Device
K193354 · IRP
Shenzhen Dongjilian Electronics Co.,...
Physical Medicine · 187d
Cleared May 28, 2020
DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic...
K200979 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 45d
Cleared May 21, 2020
BeneVision Central Monitoring System
K193391 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 167d
Cleared May 19, 2020
5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+
K200864 · PGY
Shenzhen Beacon Display Technology...
Radiology · 48d
Cleared May 12, 2020
Disposable ECG Cable
K200026 · DSA
Shenzhen Changke Connect Electronics...
Cardiovascular · 127d
Cleared May 07, 2020
Patient Monitor
K192972 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 196d
Cleared Apr 11, 2020
Nerve and Muscle Stimulator
K193275 · IPF
Shenzhen Xft Medical Limited
Physical Medicine · 137d
Cleared Apr 09, 2020
MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus...
K200001 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 98d
Cleared Apr 08, 2020
Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
K200411 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 49d
Cleared Apr 02, 2020
Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System
K200251 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 59d
Cleared Mar 25, 2020
Disposable NIBP Cuff
K193629 · DXQ
Shenzhen Changke Connect Electronics...
Cardiovascular · 90d
Cleared Mar 20, 2020
AI-ECG Tracker
K200036 · DPS
Shenzhen Carewell Electronics Co., Ltd.
Cardiovascular · 72d
Cleared Mar 16, 2020
Sunmed Disposable Angio-Closure Pads
K191827 · DXC
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 252d
Cleared Mar 14, 2020
Health Expert Electronic Stimulator (model: AST-300L)
K190783 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 353d
Cleared Mar 13, 2020
Disposable SpO2 Sensor
K200069 · DQA
Shenzhen Changke Connect Electronics...
Anesthesiology · 60d
Cleared Feb 21, 2020
Upper Arm Blood Pressure Monitor
K191894 · DXN
Shenzhen Zhengkang Technology Co., Ltd.
Cardiovascular · 221d
Cleared Feb 07, 2020
Paragon XHD Diagnostic Ultrasound System
K191347 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 263d
Cleared Jan 31, 2020
BIOEASY Multi-Drug Test Cup
K193480 · NGL
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 46d
Cleared Jan 30, 2020
GTK Veress Needles
K193339 · HIF
Guangzhou T.K Medical Instrument Co.,...
Obstetrics & Gynecology · 59d