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"
625–648 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Oct 14, 2021
Sapphire NC 24
K211807 · LOX
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 125d
Cleared Oct 07, 2021
Superior Hair Remover
K210376 · OHT
Guangzhou Haoxingwan Technology Co.,...
General & Plastic Surgery · 240d
Cleared Oct 05, 2021
Vital Signs Monitors
K211475 · MWI
Shenzhen Mindray Bio-Medical...
Cardiovascular · 146d
Cleared Oct 04, 2021
IPL Hair Remover, Model: G993, G996, G998 and G885
K211368 · ONF
Shenzhen Mywin Technology Co., Ltd.
General & Plastic Surgery · 153d
Cleared Sep 28, 2021
Surgical Face Mask (Model: CM2006, CM2008, A88)
K210878 · FXX
Shenzhen Realtone Medical Appliance...
General Hospital · 188d
Cleared Sep 24, 2021
Red Wave Hair Removal
K212099 · ONF
Shenzhen Accompany Technology Co., Ltd.
General & Plastic Surgery · 80d
Cleared Sep 24, 2021
Personal Lubricant
K210857 · NUC
Shenzhen Huanqiu Xuebao Technology...
Obstetrics & Gynecology · 185d
Cleared Sep 23, 2021
Reusable NIBP Cuff
K211747 · DXQ
Shenzhen Coreray Technology Co., Ltd.
Cardiovascular · 108d
Cleared Sep 20, 2021
IPL Home Use Hair Removal Device
K211922 · OHT
Shenzhen Beauty Every Moment...
General & Plastic Surgery · 91d
Cleared Sep 17, 2021
Incontinence Probe
K210441 · KPI
Shenzhen Med-Link Electronics Tech...
Gastroenterology & Urology · 217d
Cleared Sep 05, 2021
Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T,...
K211736 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 90d
Cleared Sep 03, 2021
Infrared Thermometer, Model: HW-1
K211583 · FLL
Dongguan Simzo Electronic Technology...
General Hospital · 102d
Cleared Sep 01, 2021
IPL Hair Removal
K211174 · OHT
Shenzhen Qiaochengli Technology Co.,...
General & Plastic Surgery · 134d
Cleared Aug 30, 2021
Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor,...
K211041 · DXN
Shenzhen Yuezhongxing Technology Co.,...
Cardiovascular · 144d
Cleared Aug 27, 2021
Clear Aligners
K210373 · NXC
Shenzhen Yinuo Dental Technology Co.Ltd
Dental · 200d
Cleared Aug 18, 2021
Surgical mask
K211454 · FXX
Jiangsu Xingtong Biotechnology Group...
General Hospital · 100d
Cleared Aug 13, 2021
Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103,...
K210671 · DXN
Weony (Shenzhen) Technology Co., Ltd.
Cardiovascular · 161d
Cleared Aug 11, 2021
Medical Face Mask
K211353 · FXX
Shenzhen Lyttop Healthcare Limited
General Hospital · 100d
Cleared Jul 30, 2021
Disposable Nitrile Examination Gloves
K211264 · LZA
Shenzhen Shiqiao Science and...
General Hospital · 95d
Cleared Jul 30, 2021
Labat series Diagnostic Ultrasound System
K210154 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 190d
Cleared Jul 23, 2021
Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B,...
K210311 · OHT
Shenzhen Mismon Technology Co., Ltd.
General & Plastic Surgery · 170d
Cleared Jul 23, 2021
Infrared Forehead Thermometer, Model BSX976
K202296 · FLL
Shenzhen Bsx Technology Electronics...
General Hospital · 344d
Cleared Jul 22, 2021
DemarkQ WOW, DemarkQ POP
K203214 · OLP
Shenzhen Kaiyan Medical CO , Ltd.
General & Plastic Surgery · 262d
Cleared Jul 21, 2021
Aduro light therapy Handheld
K203271 · OLP
Shenzhen Kaiyan Medical CO , Ltd.
General & Plastic Surgery · 257d