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"
937–960 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Dec 15, 2016
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
K162845 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 65d
Cleared Nov 28, 2016
Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
K160530 · DXQ
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 277d
Cleared Nov 22, 2016
Arm automatic blood pressure monitor
K161708 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 154d
Cleared Nov 17, 2016
Non-contact Forehead Thermometer
K161735 · FLL
Shenzhen Dongdixin Technology Co., Ltd.
General Hospital · 147d
Cleared Nov 10, 2016
Sunmed Control Syringes
K160190 · DXT
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 288d
Cleared Oct 24, 2016
Caremed patient cable and leadwires
K153188 · DSA
Shenzhen Caremed Medical Technology...
Cardiovascular · 356d
Cleared Oct 13, 2016
Sunmed Haemostatic Valves
K153685 · DQX
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 296d
Cleared Sep 30, 2016
8MP Color LCD Monitor (C81W+)
K162527 · PGY
Shenzhen Beacon Display Technology...
Radiology · 21d
Cleared Sep 06, 2016
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound...
K162267 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 26d
Cleared Sep 01, 2016
DUO
K161565 · ONF
Stetic Medical Aesthetics Development...
General & Plastic Surgery · 87d
Cleared Aug 18, 2016
Medke Oximetry Finger Sensor
K152390 · DQA
Shenzhen Medke Technology Co., Ltd.
Anesthesiology · 360d
Cleared Aug 01, 2016
8ch Foot Ankle Coil
K160932 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 119d
Cleared Jul 28, 2016
8ch Foot Ankle Coil
K160935 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 115d
Cleared Jul 13, 2016
TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System
K161525 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 41d
Cleared Jun 09, 2016
BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M...
K160370 · JGS
Shenzhen Mindray Bio-Medical...
Chemistry · 120d
Cleared May 23, 2016
Agem Ag Mesh Dressing with Silver
K152544 · FRO
Shenzhen Yuanxing Nano-Pharma Co., Ltd.
General & Plastic Surgery · 262d
Cleared Apr 22, 2016
U80 Series Upper Arm Electronic Blood Pressure Monitor
K160019 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 108d
Cleared Mar 29, 2016
X-cera Zirconia Blanks
K153767 · EIH
Shenzhen Xiangtong Photoelectricity...
Dental · 90d
Cleared Mar 09, 2016
TE7 Diagnostic Ultrasound System
K160381 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 28d
Cleared Mar 08, 2016
Mailuokang Self-adhesive Electrode
K152815 · GXY
Shenzhen Mailuokang Technology Co., Ltd.
Neurology · 162d
Cleared Mar 03, 2016
Passport Series Patient Monitors (Including Passport 8, Passport 12)
K153448 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 94d
Cleared Feb 18, 2016
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
K152902 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 140d
Cleared Feb 18, 2016
Arm automatic blood pressure monitor
K151258 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 282d
Cleared Feb 12, 2016
Digital Electrocardiograph
K160092 · DPS
Shenzhen Biocare Bio-Medical...
Cardiovascular · 28d