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"
961–984 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Jan 07, 2016
Sterile High-pressure Angiographic Syringes for Single-use
K151960 · DXT
Shenzhen Baoan Medical Supplies Co.,...
Cardiovascular · 175d
Cleared Dec 23, 2015
2-in-1 Abdominal Muscle Training & Back Pain Relief System
K152128 · NUH
Tohkai Precision Electrical...
Neurology · 145d
Cleared Dec 18, 2015
Digital Electrocardiograph
K152384 · DPS
Shenzhen Biocare Bio-Medical...
Cardiovascular · 116d
Cleared Dec 17, 2015
Bpump Blood Pressure Cuff
K151810 · DXQ
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 168d
Cleared Nov 13, 2015
ComboRehab
K150436 · IMG
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 267d
Cleared Oct 29, 2015
M9/M9CV/M9T Diagnostic Ultrasound System
K152543 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 55d
Cleared Oct 29, 2015
Reusable Blood Pressure Cuff
K152468 · DXQ
Shenzhen Vistar Medical Supplies Co.,...
Cardiovascular · 59d
Cleared Oct 29, 2015
Disposable Blood Pressure Cuff
K152465 · DXQ
Shenzhen Vistar Medical Supplies Co.,...
Cardiovascular · 59d
Cleared Oct 27, 2015
A7 Anesthesia System
K151954 · BSZ
Shenzhen Mindray Bio-Medical...
Anesthesiology · 104d
Cleared Oct 21, 2015
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound...
K152763 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 27d
Cleared Oct 02, 2015
DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems
K152545 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 24d
Cleared Sep 29, 2015
Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series
K152483 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 29d
Cleared Sep 02, 2015
V Series Monitoring System (including V12 and V21 Monitors)
K150352 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 203d
Cleared Sep 02, 2015
Panorama Patient Monitoring Network
K150082 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 230d
Cleared Aug 26, 2015
UltraTENS
K142976 · IMI
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 316d
Cleared Aug 10, 2015
Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless...
K141594 · GCJ
Unimicro Medical Systems (Shenzhen)...
General & Plastic Surgery · 423d
Cleared Aug 07, 2015
8ch Foot Ankle Coil
K151653 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 50d
Cleared Aug 07, 2015
Digital Automatic Wrist Blood Pressure Monitor MD3200
K151587 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 57d
Cleared Aug 07, 2015
Digital Automatic Wrist Blood Pressure Monitor MD3900
K151583 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 57d
Cleared Jul 31, 2015
Unimicro Veress Needle
K150068 · HIF
Unimicro Medical Systems (Shenzhen)...
Obstetrics & Gynecology · 199d
Cleared Jul 23, 2015
Digital Automatic Blood Pressure Monitor MD2300
K143735 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 205d
Cleared Jul 21, 2015
TENS AND POWERED MUSCLE STIMULATOR
K143268 · NUH
Shenzhen As-Tec Technology Co., Ltd.
Neurology · 250d
Cleared Jul 06, 2015
Electronic Pulse Stimulator
K150995 · NUH
Shenzhen Jingkehui Electronic Co.., Ltd.
Neurology · 82d
Cleared Jul 06, 2015
Hypervisor IX Monitoring System
K150632 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 117d