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"
889–912 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Jan 17, 2018
Endotracheal tube
K170234 · BTR
Zhanjiang Star Enterprise Co., Ltd.
Anesthesiology · 357d
Cleared Jan 12, 2018
A5 Anesthesia System
K171311 · BSZ
Shenzhen Mindray Bio-Medical...
Anesthesiology · 255d
Cleared Jan 12, 2018
A7 Anesthesia System
K171292 · BSZ
Shenzhen Mindray Bio-Medical...
Anesthesiology · 255d
Cleared Jan 10, 2018
Digital Blood Pressure Monitor-Wrist Style
K171833 · DXN
Shenzhen Combei Technology Co., Ltd.
Cardiovascular · 205d
Cleared Jan 10, 2018
Electrodes with snap / Electrodes with pigtail
K171722 · GXY
Shenzhen Konmed Technology Co., Ltd.
Neurology · 212d
Cleared Jan 08, 2018
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic
K173471 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 61d
Cleared Jan 05, 2018
Electrodes with silver conductive
K171721 · GXY
Shenzhen Konmed Technology Co., Ltd.
Neurology · 207d
Cleared Jan 02, 2018
Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound...
K172860 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 104d
Cleared Jan 02, 2018
Clover 50/Clover60/Clover70 Diagnostic Ultrasound System
K163712 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 368d
Cleared Dec 13, 2017
DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
K173369 · IYN
Shenzhen Mindray Bio-Meidcal...
Radiology · 47d
Cleared Dec 13, 2017
Adhesive Electrodes
K171381 · GXY
Shenzhen Quality Medical Technology...
Neurology · 216d
Cleared Dec 12, 2017
Disposable High Pressure Syringe
K170279 · DXT
Union Medical Shenzhen Co., Ltd.
Cardiovascular · 316d
Cleared Dec 08, 2017
Wireless Pain Relieve Device Model: LT5018C
K173462 · NUH
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 30d
Cleared Dec 08, 2017
8ch Flex Suite
K172222 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 137d
Cleared Nov 30, 2017
Infrared thermometer
K171578 · FLL
Shenzhen Aeon Technology Co., Ltd.
General Hospital · 183d
Cleared Nov 30, 2017
Foot Drop System (Model XFT-2001D)
K162718 · GZI
Shenzhen Xft Medical Limited
Neurology · 427d
Cleared Nov 15, 2017
uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15,...
K171901 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 142d
Cleared Nov 03, 2017
Fingertip Pulse Oximeter
K170965 · DQA
Shenzhen Jumper Medical Equipment...
Anesthesiology · 217d
Cleared Oct 27, 2017
2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)
K172815 · PGY
Shenzhen Beacon Display Technology...
Radiology · 39d
Cleared Oct 25, 2017
M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound
K172970 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 29d
Cleared Oct 18, 2017
M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System
K171579 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 140d
Cleared Oct 13, 2017
Electronic Blood Pressure Monitor
K170151 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 269d
Cleared Oct 02, 2017
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
K171978 · IPF
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 94d
Cleared Sep 21, 2017
ZS3 Ultrasound System, z.one pro Ultrasound System
K171891 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 87d