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"
673–696 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Apr 11, 2021
Medical Surgical Mask (Non-sterile)
K202761 · FXX
Guangdong Goodfeeling Hygiene...
General Hospital · 202d
Cleared Apr 09, 2021
Disposable Medical Face Mask-Model FM-04
K202513 · FXX
Shenzhen Jinko Industrial Co., Ltd.
General Hospital · 221d
Cleared Apr 08, 2021
Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa...
K202785 · IYN
Shenzhen Mindray Bio-Meidcal...
Radiology · 198d
Cleared Apr 02, 2021
Surgical Face Mask
K210023 · FXX
Guangdong Winsun Personal Care...
General Hospital · 88d
Cleared Mar 26, 2021
A8, A9 Anesthesia System
K201957 · BSZ
Shenzhen Mindray Bio-Medical...
Anesthesiology · 255d
Cleared Mar 25, 2021
Low-frequency Multi-function physiotherapy instrument
K200177 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 426d
Cleared Mar 23, 2021
TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System
K203391 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 125d
Cleared Mar 22, 2021
Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008,...
K202009 · FLL
Shenzhen Juzhong Technology Co., Ltd.
General Hospital · 244d
Cleared Mar 12, 2021
Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603
K203707 · FLL
Shenzhen Zhengkang Technology Co., Ltd.
General Hospital · 84d
Cleared Mar 10, 2021
Surgical Face Mask
K202548 · FXX
Wanxinda (Guangzhou) Technology...
General Hospital · 189d
Cleared Mar 10, 2021
Surgical Face Mask
K202161 · FXX
Hunan Eexi Technology & Service Co.,...
General Hospital · 219d
Cleared Mar 09, 2021
Disposable Medical Face Mask
K202710 · FXX
Wanxinda (Guangzhou) Technology...
General Hospital · 174d
Cleared Mar 08, 2021
Disposable Medical Face Mask
K202439 · FXX
Hunan Eexi Technology & Service Co.,...
General Hospital · 195d
Cleared Mar 04, 2021
Surgical Face Mask
K210225 · FXX
Feng Chun Yuan Medical Equipment...
General Hospital · 35d
Cleared Mar 01, 2021
Fingertip pulse oximeter
K202776 · DQA
Shenzhen Lepu Intelligent Medical...
Anesthesiology · 161d
Cleared Mar 01, 2021
Med-Link Temp-pulse Oximeter
K202743 · DQA
Shenzhen Med-Link Electronics Tech...
Anesthesiology · 164d
Cleared Feb 26, 2021
IPL Hair removal
K203510 · OHT
Shenzhen Weikai Technology Co.,Ltd
General & Plastic Surgery · 88d
Cleared Feb 18, 2021
Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60
K202687 · FLL
Shenzhen Lepu Intelligent Medical...
General Hospital · 156d
Cleared Feb 10, 2021
Infrared Forehead Thermometer
K201536 · FLL
Hangzhou Qingyuan Medical Equipment...
General Hospital · 247d
Cleared Feb 02, 2021
Easydrip Pen Needle, Easydrip Plus Pen Needle
K193422 · FMI
Sandstone Medical (Suzhou), Inc.
General Hospital · 421d
Cleared Jan 27, 2021
Arm Electronic Sphygmomanometer
K193387 · DXN
Shenzhen Changkun Technology Co., Ltd.
Cardiovascular · 418d
Cleared Jan 27, 2021
Wrist Electronic Sphygmomanometer
K193386 · DXN
Shenzhen Changkun Technology Co., Ltd.
Cardiovascular · 418d
Cleared Jan 25, 2021
Pulse Oximeter
K201468 · DQA
Shenzhen Creative Industry Co., Ltd.
Anesthesiology · 237d
Cleared Jan 15, 2021
Non-contact Electronic Forehead Infrared Thermometer
K201582 · FLL
Zhongshan Jinli Electronic Weighing?...
General Hospital · 218d