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"
73–96 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Feb 13, 2026
Wearable Breast Pump (Model W12)
K252420 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 196d
Cleared Feb 13, 2026
Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
K251581 · DXN
Shenzhen Hingmed Medical Instrument...
Cardiovascular · 266d
Cleared Feb 11, 2026
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona...
K253049 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 142d
Cleared Feb 10, 2026
GEM Flex Coil 16-L Array, 1.5T Receive Only
K252179 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 214d
Cleared Feb 06, 2026
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
K253221 · IYO
Eieling Technology (Shenzhen) Limited
Radiology · 130d
Cleared Feb 06, 2026
Dermatrix Duo
K251836 · GEI
Shenzhen Gsd Technology Co., Ltd.
General & Plastic Surgery · 235d
Cleared Jan 30, 2026
ZenTite (Unicorn+)
K254290 · GEI
Shenzhen Peninsula Medical Group
General & Plastic Surgery · 30d
Cleared Jan 30, 2026
Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003,...
K253833 · OHS
Shenzhen Jianchao Intelligent...
General & Plastic Surgery · 60d
Cleared Jan 28, 2026
HIGHERDOSE Body Sculptor (Model: GS-03)
K252603 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 163d
Cleared Jan 23, 2026
LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072,...
K253712 · OHS
Shenzhen Rainbow Technology Co., Ltd.
General & Plastic Surgery · 60d
Cleared Jan 23, 2026
TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A)
K253669 · OAP
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 63d
Cleared Jan 12, 2026
Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)
K251307 · DXN
Shenzhen Hingmed Medical Instrument...
Cardiovascular · 259d
Cleared Jan 08, 2026
Fetal Doppler U8-25, U9-25
K252669 · KNG
Zhongshan Xiaolan Town Senlan...
Obstetrics & Gynecology · 136d
Cleared Jan 08, 2026
Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P,...
K251160 · FLL
Shenzhen Med-Link Electronics Tech...
General Hospital · 268d
Cleared Jan 07, 2026
Reusable SPO2 Sensor (BSA307-47
K253109 · DQA
Shenzhen Best Electronics Co., Ltd.
Anesthesiology · 105d
Cleared Jan 07, 2026
Clear Aligner (SCF-3348)
K251454 · NXC
Beame Medical Technology (Shenzhen)...
Dental · 240d
Cleared Jan 02, 2026
Ready to use Nelaton Catheter
K251178 · EZD
Jamjoom Fullcare Corporation
Gastroenterology & Urology · 261d
Cleared Dec 31, 2025
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
K253305 · NUH
Shenzhen Jiantuo Electronics Co., Ltd.
Neurology · 93d
Cleared Dec 29, 2025
Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ,...
K253881 · OHT
Shenzhen Fansizhe Science And...
General & Plastic Surgery · 25d
Cleared Dec 24, 2025
LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1,...
K253400 · OHS
Shenzhen Saidi Light Therapy...
General & Plastic Surgery · 85d
Cleared Dec 23, 2025
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
K253740 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 29d
Cleared Dec 23, 2025
Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10,...
K253072 · HGX
Linhejiacheng (Shenzhen) E-Commerce...
Obstetrics & Gynecology · 91d
Cleared Dec 23, 2025
Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003...
K252146 · NFO
Shenzhen Siken 3D Technology...
Neurology · 167d
Cleared Dec 23, 2025
SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016)
K251991 · JOJ
Shenzhen Safesecure Medical Infection...
General Hospital · 179d