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"
913–936 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Sep 19, 2017
Finger Pulse Oximeter
K163135 · DQA
Shenzhen Fitfaith Technology Co.,Ltd
Anesthesiology · 315d
Cleared Sep 12, 2017
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound...
K171233 · IYN
Shenzhen Mindray Bio-Meidcal...
Radiology · 138d
Cleared Sep 09, 2017
All-in-One Health Monitor, PC-303
K170047 · MWI
Shenzhen Creative Industry Co., Ltd.
Cardiovascular · 247d
Cleared Sep 06, 2017
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS,...
K161586 · CAF
Shenzhen Homed Medical Device Co., Ltd.
Anesthesiology · 455d
Cleared Aug 23, 2017
Passport Series Patient Monitors(Passport 12m, Passport 17m)
K170876 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 152d
Cleared Aug 02, 2017
Accutorr 7/VS-900 Vital Signs Monitor
K170712 · MWI
Shenzhen Mindray Bio-Meidcal...
Cardiovascular · 146d
Cleared Jul 31, 2017
Electronic Blood Pressure Monitor
K161845 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 391d
Cleared Jul 14, 2017
MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer
K162698 · JLW
Shenzhen New Industries Biomedical...
Chemistry · 290d
Cleared Jul 10, 2017
M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV...
K171034 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 95d
Cleared Jul 07, 2017
Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic...
K163648 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 196d
Cleared Jun 07, 2017
Digital Automatic Blood Pressure Monitor MD3600
K163679 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 162d
Cleared Jun 02, 2017
Galvanic Spa, Model: SKB-1405
K163470 · NFO
Shenzhen Siken 3D Technology...
Neurology · 172d
Cleared May 11, 2017
Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
K170205 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 108d
Cleared May 11, 2017
Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
K161950 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 300d
Cleared May 09, 2017
Digital Blood Pressure Monitor-Automatic Upper Arm Style
K163606 · DXN
Shenzhen Combei Technology Co., Ltd.
Cardiovascular · 139d
Cleared Apr 29, 2017
Digital TENS Unit
K170145 · NUH
Shenzhen Eapply Technology Co., Ltd.
Neurology · 102d
Cleared Apr 20, 2017
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound...
K163690 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 113d
Cleared Apr 20, 2017
BeneVision Central Monitoring System
K162607 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 213d
Cleared Apr 05, 2017
Arm automatic blood pressure monitor
K161712 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 288d
Cleared Mar 31, 2017
Bluetooth blood pressure monitor
K161530 · DXN
Shenzhen Kingyield Technology Co., Ltd.
Cardiovascular · 302d
Cleared Mar 23, 2017
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System
K170277 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 52d
Cleared Feb 08, 2017
Smart Pain Reliever, Model LT5019
K162479 · NUH
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 155d
Cleared Jan 19, 2017
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series
K163113 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 73d
Cleared Jan 04, 2017
Caremed Reusable & Disposable SPO2 Sensors
K153184 · DQA
Shenzhen Caremed Medical Technology...
Anesthesiology · 428d