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"
817–840 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Apr 09, 2019
DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System
K183660 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 103d
Cleared Apr 04, 2019
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
K183377 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 119d
Cleared Apr 03, 2019
Infrared thermometer
K182597 · FLL
Shenzhen Pango Electronic Co., Ltd.
General Hospital · 195d
Cleared Mar 27, 2019
Accutorr 7/VS-900/VS-900c Vital Signs Monitor
K182821 · MWI
Shenzhen Mindray Bio-Medical...
Cardiovascular · 174d
Cleared Mar 26, 2019
SM Electrodes
K183154 · GXY
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 132d
Cleared Mar 13, 2019
BeneVision Central Monitoring System
K183238 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 113d
Cleared Mar 08, 2019
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A...
K190206 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 32d
Cleared Mar 03, 2019
Electronic Blood Pressure Monitor
K182495 · DXN
Shenzhen Jumper Medical Equipment...
Cardiovascular · 173d
Cleared Feb 28, 2019
Lifetech Cardio Model 8301 Temporary Pacemaker
K182839 · DTE
Shenzhen Lifetech Cardio Medical...
Cardiovascular · 142d
Cleared Feb 15, 2019
IPL Hair Removal Device
K183217 · OHT
Touchbeauty Beauty & Health...
General & Plastic Surgery · 88d
Cleared Jan 10, 2019
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System
K182636 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 108d
Cleared Jan 09, 2019
DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
K181637 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 202d
Cleared Jan 03, 2019
Arm Blood Pressure Monitor
K180435 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 317d
Cleared Jan 02, 2019
Infrared Thermometer
K181215 · FLL
Shenzhen Finicare Co., Ltd.
General Hospital · 240d
Cleared Dec 21, 2018
Disposable Temperature Probe
K182755 · FLL
Shenzhen Caremed Medical Technology...
General Hospital · 84d
Cleared Dec 20, 2018
Color Doppler Ultrasound System
K182165 · IYN
Shenzhen Well.D Medical Electronics...
Radiology · 132d
Cleared Dec 19, 2018
Fetal Doppler
K182190 · KNG
Shenzhen AOJ Medical Technology Co.,...
Obstetrics & Gynecology · 128d
Cleared Dec 17, 2018
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
K182433 · DXQ
Shenzhen Caremed Medical Technology...
Cardiovascular · 102d
Cleared Dec 17, 2018
Handheld VitalSigns Monitoring System
K172965 · MWI
Visiomed Technology Co.,Ltd
Cardiovascular · 447d
Cleared Dec 10, 2018
BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision...
K182075 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 131d
Cleared Dec 10, 2018
Disposable Temperature Probe
K181967 · FLL
Shenzhen Launch Electrical Co., Ltd.
General Hospital · 140d
Cleared Dec 07, 2018
Neck Care Therapy, Model: SYK 509B
K172897 · NUH
Shenzhen Osto Technology Co., Ltd.
Neurology · 441d
Cleared Nov 28, 2018
Non-contact Infrared Thermometer
K180207 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 308d
Cleared Nov 26, 2018
Low-frequency Multi-function physiotherapy instrument
K172837 · NUH
Shenzhen Osto Technology Co., Ltd.
Neurology · 433d