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"
697–720 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Jan 15, 2021
Infrared Thermometer
K201579 · FLL
Shenzhen Xunwei Industrial Co., Ltd.
General Hospital · 218d
Cleared Jan 07, 2021
BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision...
K202405 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 139d
Cleared Jan 05, 2021
Insulin Syringe
K193273 · FMF
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 406d
Cleared Dec 23, 2020
LUBi Water Based Personal Lubricant
K203257 · NUC
Boya Biotechnology Co., Ltd.
Obstetrics & Gynecology · 49d
Cleared Dec 17, 2020
Aidite PMMA
K190217 · EBG
Aidite (Qinhuangdao) Technology Co.,...
Dental · 682d
Cleared Dec 15, 2020
308nm Excimer UV-light Skin Therapy System
K202827 · FTC
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 82d
Cleared Dec 14, 2020
Fingertip Pulse Oximeter
K202324 · DQA
Shenzhen Bsx Technology Electronics...
Anesthesiology · 119d
Cleared Dec 11, 2020
TENS & PMS
K201354 · NGX
Hong Qiangxing (Shenzhen) Electronics...
Physical Medicine · 204d
Cleared Dec 10, 2020
JADE
K202231 · LIT
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 125d
Cleared Dec 08, 2020
Biofeedback Nerve and Muscle Stimulator
K202648 · IPF
Shenzhen Konmed Technology Co., Ltd.
Physical Medicine · 88d
Cleared Dec 07, 2020
Pulse Oximeter
K202173 · DQA
Shenzhen AOJ Medical Technology Co.,...
Anesthesiology · 126d
Cleared Dec 07, 2020
Pulse Oximeter
K201384 · DQA
Shenzhen Raysintone Technology Co., Ltd.
Anesthesiology · 195d
Cleared Dec 04, 2020
Electronic Blood Pressure Monitor
K200716 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 261d
Cleared Nov 23, 2020
Medical surgical mask
K201991 · FXX
Shenzhen Everwin Precision Technology...
General Hospital · 129d
Cleared Nov 19, 2020
Laser Therapy Device
K202980 · GEX
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 50d
Cleared Nov 19, 2020
Air Compression Therapy Device
K201694 · IRP
Shenzhen Dongjilian Electronics Co.,...
Physical Medicine · 150d
Cleared Nov 18, 2020
TrueView 100 Pro
K202713 · MWP
Compai Healthcare (Shenzhen) Co.,Ltd
Radiology · 63d
Cleared Nov 09, 2020
DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound...
K201990 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 115d
Cleared Oct 23, 2020
Infrared ear and forehead thermometer, model YI-100
K201843 · FLL
Wenzhou Yosun Medical Technology Co.,Ltd
General Hospital · 109d
Cleared Oct 19, 2020
4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+
K202374 · PGY
Shenzhen Beacon Display Technology...
Radiology · 61d
Cleared Oct 19, 2020
Transcutaneous Electronic Nerve Stimulator
K200237 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 269d
Cleared Oct 16, 2020
VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro®...
K200408 · MQL
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology · 240d
Cleared Oct 07, 2020
Infrared Thermometer
K200802 · FLL
Shenzhen Urion Technology Co., Ltd.
General Hospital · 194d
Cleared Oct 05, 2020
Neonatal Phototherapy System
K200031 · LBI
Avalon Biomedical (Shenzhen) Limited
General Hospital · 272d