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"
385–408 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Dec 11, 2023
Hygenix
K232797 · FXX
Shenzhen Hygenix Industrial Co., Ltd.
General Hospital · 90d
Cleared Dec 11, 2023
iFlash-HCG
K223690 · DHA
Shenzhen Yhlo Biotech Co., Ltd.
Chemistry · 367d
Cleared Dec 08, 2023
Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302,...
K232517 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 112d
Cleared Dec 07, 2023
Light Based Hair Removal Device
K232846 · OHT
Shenzhen Meik Beauty Industry Co., Ltd.
General & Plastic Surgery · 84d
Cleared Dec 04, 2023
Intense Pulse Light Therapeutic Apparatus
K232932 · OHT
Shenzhen Greatro Electronic...
General & Plastic Surgery · 75d
Cleared Nov 29, 2023
Blood Pressure Cuff...
K232772 · DXQ
Shenzhen Plinma Technology Co. , Ltd.
Cardiovascular · 79d
Cleared Nov 28, 2023
Digital Blood Pressure Monitor
K231250 · DXN
Guangdong Genial Technology Co., Ltd.
Cardiovascular · 211d
Cleared Nov 27, 2023
Portable (Ultrasonic) Nebulizer
K230379 · CAF
Dongguan Simzo Electronic Technology...
Anesthesiology · 287d
Cleared Nov 21, 2023
Absorbable Cranial Flap Fixation System
K221606 · GXR
Chendu Medart Medical Scientific Co.,...
Neurology · 537d
Cleared Nov 20, 2023
Hair Removal Device, Model(s): R2815-G Pro, R2815-G
K232575 · OHT
Shenzhen Jianchao Intelligent...
General & Plastic Surgery · 87d
Cleared Nov 14, 2023
IPL Cooling Hair Removal Device
K232845 · OHT
Shenzhen Siken 3D Technology...
General & Plastic Surgery · 61d
Cleared Nov 13, 2023
Cystoscope System
K231118 · FAJ
Shenzhen HugeMed Medical Technical...
Gastroenterology & Urology · 207d
Cleared Nov 03, 2023
Combo Electrotherapy Device
K231440 · IPF
Shenzhen Roundwhale Technology Co. ,...
Physical Medicine · 169d
Cleared Oct 27, 2023
Electronic Blood Pressure Monitor
K231310 · DXN
Shenzhen Jumper Medical Equipment...
Cardiovascular · 175d
Cleared Oct 26, 2023
TE Air Diagnostic Ultrasound System
K231685 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 139d
Cleared Oct 26, 2023
Electric Breast Pump
K231595 · HGX
Shenzhen Changkun Technology Co., Ltd.
Obstetrics & Gynecology · 147d
Cleared Oct 24, 2023
Laser Cap, Model: Hat-01
K232356 · OAP
Hubei Yjt Technology Co.,Ltd
General & Plastic Surgery · 78d
Cleared Oct 20, 2023
NexPort™ Trocar System (TS211001)
K232042 · GCJ
Mediconcepts Technology (Shenzhen)...
General & Plastic Surgery · 102d
Cleared Oct 19, 2023
Radio Frequency System
K231749 · GEI
Shenzhenshi Sincoheren S&T...
General & Plastic Surgery · 126d
Cleared Oct 14, 2023
Infrared Thermometer (AOJ-20A)
K232128 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 89d
Cleared Oct 11, 2023
IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)
K232499 · OHT
Shenzhen Lescolton Electrical...
General & Plastic Surgery · 55d
Cleared Oct 11, 2023
Disposable electrosurgical pencil (MD1000)
K232460 · GEI
Shenzhen Mecun Medical Supply Co., Ltd.
General & Plastic Surgery · 57d
Cleared Oct 11, 2023
Arm Blood Pressure Monitor
K231050 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 181d
Cleared Sep 28, 2023
IPL hair removal device
K232274 · OHT
Lumenessa Corp
General & Plastic Surgery · 59d