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"
841–864 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Nov 20, 2018
Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System
K182715 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 54d
Cleared Nov 20, 2018
6MP Color LCD Monitor (C61W+)
K182291 · PGY
Shenzhen Beacon Display Technology...
Radiology · 89d
Cleared Nov 20, 2018
Infrared Thermometer
K182133 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 106d
Cleared Nov 19, 2018
AI-ECG Platform
K180432 · DQK
Shenzhen Carewell Electronics., Ltd.
Cardiovascular · 272d
Cleared Nov 14, 2018
Z6 Diagnostic Ultrasound System
K182603 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 54d
Cleared Nov 13, 2018
Handheld Pulse Oximeter, Model SP-20
K172792 · DQA
Shenzhen Creative Industry Co., Ltd.
Anesthesiology · 424d
Cleared Nov 09, 2018
BIOEASY Multi-Drug Test Cup
K182530 · NFT
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 56d
Cleared Oct 24, 2018
Gas Module 3
K180788 · BZK
Shenzhen Mindray Bio-Medical...
Anesthesiology · 212d
Cleared Oct 17, 2018
Muscle Trainer
K181728 · NGX
Shenzhen Kentro Medical Electronics...
Physical Medicine · 110d
Cleared Oct 10, 2018
Sterile High-pressure Angiographic Syringes for Single-use
K182289 · DXT
Shenzhen Baoan Medical Supplies Co.,...
Cardiovascular · 48d
Cleared Oct 06, 2018
Bluetooth blood pressure monitor
K182018 · DXN
Shenzhen Kingyield Technology Co., Ltd.
Cardiovascular · 71d
Cleared Oct 04, 2018
MAGLUMI 2000 FT4
K182423 · CEC
Shenzhen New Industries Biomedical...
Chemistry · 28d
Cleared Sep 15, 2018
ThermaCare Quick Therapy TENS
K181102 · NUH
Pfizer, Inc.
Neurology · 142d
Cleared Sep 07, 2018
R-C1 TENS and EMS Stimulator
K181688 · IPF
Shenzhen Roundwhale Technology Co. ,...
Physical Medicine · 73d
Cleared Sep 06, 2018
Dual output digital therapy massager
K172834 · NUH
Shenzhen Osto Technology Co., Ltd.
Neurology · 352d
Cleared Aug 31, 2018
Reusable & Disposable SpO2 Sensors
K173368 · DQA
Shenzhen Coreray Technology, Ltd.
Anesthesiology · 309d
Cleared Aug 29, 2018
Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic...
K181104 · DXN
Shenzhen Combei Technology Co., Ltd.
Cardiovascular · 125d
Cleared Aug 29, 2018
Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set
K180073 · MQL
Shenzhen Vitavitro Bio-Tech Co., Ltd.
Obstetrics & Gynecology · 232d
Cleared Aug 16, 2018
Multi-parameter Patient Monitor, models C30
K173454 · MHX
Shenzhen Comen Medical Instruments...
Cardiovascular · 283d
Cleared Aug 13, 2018
Pulse Oximeter
K173123 · DQA
Shenzhen Imdk Medical Technology Co.,...
Anesthesiology · 318d
Cleared Aug 07, 2018
Self-adhesive Electrode
K181234 · GXY
Dong Guan OU Kang Electronics Co., Ltd.
Neurology · 90d
Cleared Aug 02, 2018
Med-link Reusable Blood Pressure Cuff
K173869 · DXQ
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 225d
Cleared Jul 30, 2018
TE7/TE5 Diagnostic Ultrasound System
K180912 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 115d
Cleared Jul 19, 2018
Ultrasonic Doppler (Model YM-2T8)
K180419 · KNG
Shenzhen Imdk Medical Technology Co.,...
Obstetrics & Gynecology · 154d