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"
721–744 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Oct 01, 2020
ECG Cables and Leadwires
K201359 · DSA
Xinkang Medical Instrument Co. , Ltd.
Cardiovascular · 133d
Cleared Sep 25, 2020
Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230,...
K191982 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 428d
Cleared Sep 23, 2020
Pulse Oximeter
K200414 · DQA
Shenzhen Aeon Technology Co., Ltd.
Anesthesiology · 217d
Cleared Sep 23, 2020
Nerve and Muscle Stimulator
K193276 · GZI
Shenzhen Xft Medical Limited
Neurology · 302d
Cleared Sep 19, 2020
B&J DVT Calf/Thigh Garments, Models 801/830 Series
K201532 · JOW
B&J Manufacturing , Ltd.
Cardiovascular · 103d
Cleared Sep 18, 2020
B&J DVT Foot Garments, Models 820 Series
K201547 · JOW
B&J Manufacturing , Ltd.
Cardiovascular · 101d
Cleared Sep 03, 2020
3MP Color LCD Monitors C32S+, C32SP+
K201211 · PGY
Shenzhen Beacon Display Technology...
Radiology · 121d
Cleared Aug 25, 2020
Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes
K193338 · FLL
Shenzhen Med-Link Electronics Tech...
General Hospital · 267d
Cleared Aug 21, 2020
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A...
K201693 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 60d
Cleared Aug 19, 2020
Reusable and Disposable SpO2 Sensors
K201360 · DQA
Xinkang Medical Instrument Co. , Ltd.
Anesthesiology · 90d
Cleared Aug 18, 2020
Coloring Liquid
K192723 · EIH
Aidite (Qinhuangdao) Technology Co.,...
Dental · 326d
Cleared Aug 07, 2020
Sterile High-pressure Angiographic Syringes for Single-use
K192657 · DXT
Shenzhen Boon Medical Supply Co., Ltd.
General Hospital · 317d
Cleared Jul 28, 2020
Jade
K201794 · LIT
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 28d
Cleared Jul 24, 2020
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus...
K200643 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 135d
Cleared Jul 24, 2020
Disposable Temperature Probe
K193625 · FLL
Shenzhen Changke Connect Electronics...
General Hospital · 211d
Cleared Jul 22, 2020
8ch Flex Suite
K200836 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 113d
Cleared Jul 10, 2020
B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System
K200568 · JOW
B&J Manufacturing , Ltd.
Cardiovascular · 128d
Cleared Jul 09, 2020
GTK Trocars
K193272 · GCJ
Guangzhou T.K Medical Instrument Co.,...
General & Plastic Surgery · 226d
Cleared Jul 08, 2020
B&J DVT Compression Devices MHH800/MHH800SQ
K200154 · JOW
B&J Manufacturing , Ltd.
Cardiovascular · 168d
Cleared Jul 08, 2020
Dental Glass Ceramics Blocks
K192231 · EIH
Aidite (Qinhuangdao) Technology Co.,...
Dental · 327d
Cleared Jul 02, 2020
2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+
K201599 · PGY
Shenzhen Beacon Display Technology...
Radiology · 20d
Cleared Jun 29, 2020
Electronic stimulator
K200354 · NUH
Shenzhen Dongjilian Electronics Co.,...
Neurology · 137d
Cleared Jun 25, 2020
Blood Pressure Monitor
K200437 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 122d
Cleared Jun 25, 2020
Blood Pressure Monitor
K193348 · DXN
Shenzhen Viatom Technology Co., Ltd.
Cardiovascular · 205d