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"
769–792 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Jan 24, 2020
Disposable SpO2 Sensor
K192608 · DQA
Shenzhen Sino-K Medical Technology...
Anesthesiology · 126d
Cleared Jan 17, 2020
MAGLUMI 2000 HCG/ß-HCG
K192547 · DHA
Shenzhen New Industries Biomedical...
Chemistry · 122d
Cleared Dec 31, 2019
Patient Monitor
K192343 · DQA
Shenzhen Creative Industry Co., Ltd.
Cardiovascular · 125d
Cleared Dec 19, 2019
ZS3 and z.one pro Ultrasound Systems
K192410 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 106d
Cleared Dec 19, 2019
The RHEA Vital Sign Vigilance System
K190775 · BZQ
Shenzhen Fiber Medical Technology Co....
Anesthesiology · 268d
Cleared Dec 13, 2019
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ...
K192152 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 126d
Cleared Dec 13, 2019
C50 and C80 Multi-parameter Patient Monitor
K191106 · MHX
Shenzhen Comen Medical Instruments...
Cardiovascular · 232d
Cleared Dec 13, 2019
Infrared Thermometer, model: PC808
K190717 · FLL
Shenzhen Pacom Medical Instruments...
General Hospital · 268d
Cleared Dec 12, 2019
Health Expert Electronic Stimulator
K190673 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 272d
Cleared Dec 09, 2019
Dental high speed handpiece, Dental low speed handpiece
K181900 · EFB
Foshan Cicada Dental Instrument Co, Ltd.
Dental · 511d
Cleared Dec 06, 2019
Disposable SpO2 Sensor
K191279 · DQA
Shenzhen Caremed Medical Technology...
Anesthesiology · 207d
Cleared Dec 02, 2019
Checkme O2 Pulse Oximeter
K191088 · DQA
Shenzhen Viatom Technology Co., Ltd.
Anesthesiology · 222d
Cleared Dec 02, 2019
Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
K190009 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 333d
Cleared Nov 27, 2019
ECG Cable
K191428 · DSA
Shenzhen Changke Connect Electronics...
Cardiovascular · 182d
Cleared Nov 13, 2019
Infrared Thermometer Model MD-H30
K191570 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 153d
Cleared Nov 08, 2019
IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129,...
K192432 · OHT
Shenzhen Bosidin Technology Co., Ltd.
General & Plastic Surgery · 64d
Cleared Nov 01, 2019
Combo Electrotherapy Device
K192087 · NUH
Shenzhen Roundwhale Technology Co. ,...
Neurology · 88d
Cleared Oct 31, 2019
ePM Series Patient monitors
K191769 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 122d
Cleared Oct 18, 2019
Pulse Oximeter
K191430 · DQA
Shenzhen Yimi Life-Technology Co., Ltd.
Anesthesiology · 142d
Cleared Oct 15, 2019
Infared Thermometer
K191251 · FLL
Shenzhen Calibeur Industries Co., Ltd.
General Hospital · 159d
Cleared Oct 11, 2019
BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20,...
K192515 · LDJ
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 28d
Cleared Oct 11, 2019
Reusable SpO2 Sensor
K191420 · DQA
Shenzhen Changke Connect Electronics...
Anesthesiology · 136d
Cleared Oct 11, 2019
Electronic Pulse Stimulator
K183674 · NUH
Shenzhen Leading Perfection...
Neurology · 288d
Cleared Oct 10, 2019
Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
K182136 · NUH
Shenzhen Osto Technology Co., Ltd.
Neurology · 430d