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"
289–312 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Oct 04, 2024
Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113,...
K242721 · DXN
Shenzhen Finicare Co., Ltd.
Cardiovascular · 24d
Cleared Oct 04, 2024
Single use flexible ureteroscope (UR-D1)
K240074 · FGB
Shenzhen Besdata Technology Co., Ltd.
Gastroenterology & Urology · 268d
Cleared Sep 27, 2024
HIGHERDOSE Red and Infrared Light Mask (MK66-L)
K241933 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 87d
Cleared Sep 23, 2024
IPL Hair Removal Device (BE932C, BE932D, BE932E)
K241834 · OHT
Shenzhen Yang WO Electronic Co., Ltd.
General & Plastic Surgery · 90d
Cleared Sep 16, 2024
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10...
K241201 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 139d
Cleared Sep 12, 2024
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8...
K241432 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 114d
Cleared Sep 12, 2024
Hipro Glycosylated Hemoglobin (HbA1c) Test System
K220999 · PDJ
Shijiazhuang Hipro Biotechnology Co.,...
Chemistry · 892d
Cleared Sep 09, 2024
TENS & EMS Stimulator (MHD-1083)
K241678 · NUH
Shenzhen Minghuangda Electronics Co.,...
Neurology · 90d
Cleared Sep 09, 2024
Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM,...
K241205 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 132d
Cleared Sep 05, 2024
Cold Sore Device (QPZ-03)
K241155 · OKJ
Shenzhen Nuon Medical Equipment Co.,...
General & Plastic Surgery · 133d
Cleared Aug 29, 2024
IPL Hair Removal Device (JM-843, JM-865, JM-638)
K241881 · OHT
Shenzhen Junmei Technology Co., Ltd.
General & Plastic Surgery · 62d
Cleared Aug 22, 2024
Introducer Sheath Kits
K242248 · DYB
Beijing Demax Medical Technology Co.,Ltd
Cardiovascular · 22d
Cleared Aug 22, 2024
Single-use Sterile High-pressure Angiographic Syringes and Accessories
K241109 · DXT
Shenzhen Boon Medical Supply Co., Ltd.
General Hospital · 122d
Cleared Aug 19, 2024
OmniTrans Transport System
K240235 · JSM
Shenzhen Dakewe Bio-Engineering Co.,...
Microbiology · 203d
Cleared Aug 16, 2024
VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
K240307 · MQF
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology · 196d
Cleared Aug 16, 2024
Sapphire NC ULTRA Coronary Dilatation Catheter
K233499 · LOX
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 290d
Cleared Aug 16, 2024
Mecun SpO2 sensor
K231979 · DQA
Shenzhen Mecun Medical Supply Co., Ltd.
Anesthesiology · 408d
Cleared Aug 15, 2024
Sapphire ULTRA Coronary Dilatation Catheter
K233505 · LOX
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 289d
Cleared Aug 02, 2024
Air compression leg massager
K240981 · IRP
Huizhou Xinyi Technology Co., Ltd.
Physical Medicine · 114d
Cleared Jul 23, 2024
TE Air Diagnostic Ultrasound System
K240906 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 112d
Cleared Jul 22, 2024
Transcutaneous Electrical Nerve Stimulator (K6106)
K241119 · NUH
Shenzhen Yicai Health Technology Co.,...
Neurology · 90d
Cleared Jul 10, 2024
IPL Hair Removal Device (YT01,YT02,YT03,YT04)
K240016 · OHT
Shenzhen Jianrong Biomedical...
General & Plastic Surgery · 190d
Cleared Jul 09, 2024
IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130,...
K241343 · OHT
Shenzhen Lescolton Electrical...
General & Plastic Surgery · 57d
Cleared Jul 03, 2024
Upper Arm Electronic Blood Pressure Monitor
K241129 · DXN
Shenzhen Goodlymed Technology Co., Ltd.
Cardiovascular · 70d