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"
865–888 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Jul 12, 2018
Infrared Thermometer
K172874 · FLL
Shenzhen Jiacom Technology CO ., Ltd.
General Hospital · 294d
Cleared Jul 11, 2018
Transcranial Doppler Ultrasound System
K173801 · IYN
Shenzhen Delica Medical Equipment...
Radiology · 209d
Cleared Jun 22, 2018
Wireless Pain Relieve Device
K180331 · NUH
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 136d
Cleared Jun 21, 2018
HOMED Mesh Nebulizer
K170886 · CAF
Shenzhen Homed Medical Device Co., Ltd.
Anesthesiology · 451d
Cleared Jun 07, 2018
Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS...
K180956 · NUH
Shenzhen Roundwhale Technology Co. ,...
Neurology · 56d
Cleared Jun 07, 2018
Digital Thermometer
K172121 · FLL
Fudakang Industrial Co., Ltd.
General Hospital · 329d
Cleared Jun 05, 2018
Oximeter
K173045 · DQA
Shenzhen Greatmade Tech Limited
Anesthesiology · 250d
Cleared May 25, 2018
Infrared Thermometer
K172889 · FLL
Shenzhen Pacom Medical Instruments...
General Hospital · 246d
Cleared May 17, 2018
Infrared Thermometer
K172894 · FLL
Shenzhen Jiacom Technology CO ., Ltd.
General Hospital · 237d
Cleared May 11, 2018
Light based hair removal device
K180383 · OHT
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 88d
Cleared May 09, 2018
Navi e/Navi s/Navi X Diagnostic Ultrasound System
K180461 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 78d
Cleared Apr 10, 2018
Digital Automatic Wrist Blood Pressure Monitor MD4300
K171379 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 334d
Cleared Apr 04, 2018
Master-Frank N95 Particulate Respirator
K172963 · MSH
Master & Frank Enterprise Co., Ltd.
General Hospital · 190d
Cleared Mar 20, 2018
Home Use IPL Beauty Device
K180016 · OHT
Shenzhen Mismon Technology Co., Ltd.
General & Plastic Surgery · 77d
Cleared Mar 15, 2018
Incontinence Treatment Device, Model LT2061
K171430 · KPI
Shenzhen Dongdixin Technology Co., Ltd.
Gastroenterology & Urology · 304d
Cleared Mar 14, 2018
Infrared Thermometer
K172795 · FLL
Shenzhen Jumper Medical Equipment...
General Hospital · 180d
Cleared Mar 02, 2018
Wrist Type Automatic Blood Pressure Monitor
K172972 · DXN
Shenzhen Jiacom Technology CO ., Ltd.
Cardiovascular · 157d
Cleared Mar 02, 2018
Infrared Thermometer
K171214 · FLL
Shenzhen Brav Electronic Technologies...
General Hospital · 311d
Cleared Feb 28, 2018
ECG Cable/Leadwires
K172797 · DSA
Shenzhen Coreray Technology, Ltd.
Cardiovascular · 166d
Cleared Feb 26, 2018
Bluetooth blood pressure monitor
K171668 · DXN
Visiomed Group SA
Cardiovascular · 266d
Cleared Feb 13, 2018
Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical...
K171825 · GEI
Hunan Handlike Minimally Invasive...
General & Plastic Surgery · 239d
Cleared Feb 12, 2018
Home Use Hair Removal Device/T1, T2, T3
K172883 · OHT
Shenzhen Mareal Tech Co., Ltd.
General & Plastic Surgery · 144d
Cleared Jan 26, 2018
Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A,...
K172896 · DXN
Shenzhen Jiacom Technology CO ., Ltd.
Cardiovascular · 126d
Cleared Jan 18, 2018
Pelvifine Pelvic Muscle Trainer
K163288 · KPI
Shenzhen Konmed Technology Co., Ltd.
Gastroenterology & Urology · 422d