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"
217–240 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Apr 03, 2025
Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic...
K243298 · IYN
Carbon (Shenzhen) Medical Device Co.,...
Radiology · 167d
Cleared Apr 02, 2025
eufy Wearable Breast Pump S1 (T8D02) Model T8D02
K250152 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 71d
Cleared Mar 26, 2025
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)
K250194 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 62d
Cleared Mar 20, 2025
Ameda GLO Wearable Breast Pump (Model W8S)
K250463 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 30d
Cleared Mar 20, 2025
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)
K241884 · LPL
Hunan Haipuming Technology Co., Ltd.
Ophthalmic · 265d
Cleared Mar 19, 2025
IPL Hair Removal Device (BE965A, BE965B, BE965C)
K250171 · OHT
Shenzhen Yang WO Electronic Co., Ltd.
General & Plastic Surgery · 57d
Cleared Mar 18, 2025
Aglaia LED Beauty Device (BP-D2309)
K250413 · OHS
Shenzhen Perfect Idea Technology Limited
General & Plastic Surgery · 33d
Cleared Mar 17, 2025
Air Compression Leg Massager (K-705)
K242140 · IRP
Jiale Health Technology Shenzhen Co.,...
Physical Medicine · 238d
Cleared Mar 14, 2025
Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope:...
K242010 · EOQ
Shenzhen Sanping Image Technology...
Ear, Nose, Throat · 247d
Cleared Mar 13, 2025
Photon Therapy Apparatus (BL-10)
K243993 · GEX
Xemis Medical Technology (Shenzhen)...
General & Plastic Surgery · 77d
Cleared Mar 12, 2025
Walking rehabilitation training electric wheelchair (ZW518)
K243783 · IPL
Shenzhen Zuowei Technology Co., Ltd.
Physical Medicine · 93d
Cleared Mar 07, 2025
Apex Locator
K242383 · LQY
Shenzhen Rogin Medical Co., Ltd.
Dental · 207d
Cleared Mar 03, 2025
EnergyLounger (TY-01)
K241947 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 243d
Cleared Feb 28, 2025
Pulse Oximeter ( PO2, PO2A, PO2B)
K242876 · DQA
Shenzhen Viatom Technology Co., Ltd.
Anesthesiology · 158d
Cleared Feb 21, 2025
Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including...
K243115 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 144d
Cleared Feb 21, 2025
Wearable breast pump (model W8)
K242850 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 154d
Cleared Feb 21, 2025
Synthetic Bone Graft Particulate
K241186 · LYC
Shenzhen Dazhou Medical Technology...
Dental · 298d
Cleared Feb 19, 2025
Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4,...
K243206 · IRP
Sichuan Qianli-Beoka Medical...
Physical Medicine · 141d
Cleared Feb 19, 2025
Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323,...
K241578 · DXN
Shenzhen Bsx Technology Electronics...
Cardiovascular · 261d
Cleared Feb 14, 2025
Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202,...
K243136 · FLL
Shenzhen Finicare Co., Ltd.
General Hospital · 137d
Cleared Feb 14, 2025
CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F,...
K242593 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 168d
Cleared Feb 05, 2025
LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B,...
K243555 · OLP
Shenzhen Eyco Technology Co., Ltd.
General & Plastic Surgery · 79d
Cleared Feb 03, 2025
JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK,...
K243393 · NFO
Shenzhen Ulike Smart Electronics Co.,...
Neurology · 95d
Cleared Jan 30, 2025
Wrist Blood Pressure Monitor (OHMS11, OHMS12)
K242568 · DXN
Shenzhen Zhongkemingwang...
Cardiovascular · 154d