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"
145–168 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Sep 05, 2025
ViewMate™ Multi Ultrasound System (VMM-ICE-01)
K251250 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 135d
Cleared Sep 04, 2025
KALA MINI 2.0 (KALA-04)
K251781 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 85d
Cleared Aug 29, 2025
GLAM LED Facial Mask (TB-2386F)
K251727 · GEX
Touchbeauty Beauty & Health...
General & Plastic Surgery · 85d
Cleared Aug 28, 2025
SV600, SV800 Ventilator
K243767 · CBK
Shenzhen Mindray Bio-Medical...
Anesthesiology · 265d
Cleared Aug 22, 2025
Diagnostic Ultrasound System (MX7)
K251192 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 127d
Cleared Aug 21, 2025
LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)
K251588 · OHS
Shenzhen Fittop Health Technology...
General & Plastic Surgery · 90d
Cleared Aug 21, 2025
Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/...
K250784 · NUH
Shenzhen Yicai Health Technology Co.,...
Neurology · 160d
Cleared Aug 20, 2025
Wearable Breast Pump (Model W6)
K250383 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 190d
Cleared Aug 14, 2025
IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A,...
K251176 · OHT
Shenzhen Mlay Intelligent Technology...
General & Plastic Surgery · 120d
Cleared Aug 14, 2025
TRUDERMAL Pro (ZLD-390)
K251012 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 134d
Cleared Aug 14, 2025
WinForth (LM-E470KA)
K250916 · PBX
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 140d
Cleared Aug 11, 2025
eufy Wearable Breast Pump S1 (T8D02)
K250207 · HGX
Anker Innovations Limited
Obstetrics & Gynecology · 199d
Cleared Aug 07, 2025
LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)
K251667 · OHS
Shenzhen Liyoutong Technology Co., Ltd.
General & Plastic Surgery · 69d
Cleared Aug 06, 2025
Digital Radiographic Imaging Acquisition Software - DR (RiasDR)
K251038 · LLZ
Shen Zhen Cambridge-Hit Co., Ltd.
Radiology · 125d
Cleared Aug 01, 2025
IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)
K251707 · OHT
Shenzhen Huachuangtong Industrial...
General & Plastic Surgery · 59d
Cleared Jul 31, 2025
Wearable Breast Pump (Model FS12A)
K250843 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 133d
Cleared Jul 31, 2025
BeneVision Central Monitoring System
K242728 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 324d
Cleared Jul 30, 2025
Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)
K251076 · GEX
Shenzhen Lifotronic Technology Co., Ltd.
General & Plastic Surgery · 113d
Cleared Jul 24, 2025
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU,...
K251984 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 27d
Cleared Jul 15, 2025
Thrive 2-in-1 Breast Pump (Model P3)
K250350 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 158d
Cleared Jul 14, 2025
Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD,...
K251173 · OHT
Shenzhen Fansizhe Science And...
General & Plastic Surgery · 89d
Cleared Jul 11, 2025
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP,...
K250942 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 105d
Cleared Jul 11, 2025
KALA Therapy Wand (Model: KALA-03)
K250761 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 120d
Cleared Jul 11, 2025
Disposable Biopsy Needle
K243296 · KNW
Carbon (Shenzhen) Medical Device Co.,...
General & Plastic Surgery · 266d