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"
97–120 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Dec 22, 2025
Portable oxygen concentrator (JLO-190P)
K252616 · CAW
Shenzhen Homed Medical Device Co., Ltd.
Anesthesiology · 125d
Cleared Dec 19, 2025
LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)
K253054 · OHS
Shenzhen Xinlong Precision Plastic...
General & Plastic Surgery · 88d
Cleared Dec 19, 2025
LCD Monitor (CL1902A, CL2103F)
K252780 · PGY
Shenzhen Beacon Display Technology...
Radiology · 108d
Cleared Dec 19, 2025
Spo2 Sensor CSS032D
K251751 · DQA
Shenzhen Ykd Technology Co., Ltd.
Anesthesiology · 193d
Cleared Dec 17, 2025
Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)
K252983 · OHS
Shenzhen Goodwind Technology...
General & Plastic Surgery · 90d
Cleared Dec 17, 2025
Multi-parameter Patient Monitor (N10)
K250854 · MHX
Shenzhen Comen Medical Instruments...
Cardiovascular · 271d
Cleared Dec 16, 2025
V series portable oxygen concentrator (V5, V5C, V6, V6C)
K252268 · CAW
Shenzhen Harveymed Technology Co., Ltd.
Anesthesiology · 148d
Cleared Dec 15, 2025
Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml,...
K252935 · NUC
Foshan Pingchuang Medical Technology...
Obstetrics & Gynecology · 91d
Cleared Dec 08, 2025
Glass Ceramic
K252789 · EIH
Shenzhen Xiangtong Co., Ltd.
Dental · 97d
Cleared Dec 08, 2025
Sequential Compression System (SCD600)
K250190 · JOW
Shenzhen Comen Medical Instruments...
Cardiovascular · 319d
Cleared Dec 05, 2025
Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909,...
K252142 · OHS
Shenzhen Siken 3D Technology...
General & Plastic Surgery · 150d
Cleared Dec 03, 2025
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus...
K251601 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 190d
Cleared Dec 01, 2025
Led Light Phototherapy Bed (Pro 450/ GY-680A)
K252786 · OLI
Shenzhen Suyzeko Limited.
General & Plastic Surgery · 90d
Cleared Nov 25, 2025
LeafPure-Echo (LM-LPNdA)
K253219 · GEX
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 57d
Cleared Nov 20, 2025
MAGNETOM Free.Max
K251822 · LNH
Siemens Shenzhen Magnetic Resonance ,...
Radiology · 160d
Cleared Nov 19, 2025
Microcurrent Facial Device (CEC101, EEI101)
K252642 · OHS
Shenzhen Dachi Communication Co., Ltd.
General & Plastic Surgery · 90d
Cleared Nov 13, 2025
Air Compression Therapy Device (ST-504)
K251662 · IRP
Shenzhen Future Electronic Co., Ltd.
Physical Medicine · 167d
Cleared Nov 07, 2025
Medical Diode Laser Systems (VeinCure)
K252564 · GEX
Baoding Te'Anzhou Electronic...
General & Plastic Surgery · 85d
Cleared Nov 07, 2025
Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER,...
K251853 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 143d
Cleared Nov 06, 2025
Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
K251004 · OXO
Hefei Chimed Intelligent Machine Co.,...
Radiology · 219d
Cleared Nov 04, 2025
Tamburo Thulium Fiber Laser System
K251303 · GEX
Menovex Medical Technology (Shenzhen)...
General & Plastic Surgery · 190d
Cleared Oct 31, 2025
Flexible Ureterorenoscope system (Electronic Endoscope Image Processor,...
K250917 · FGB
Shenzhen Sanping Image Technology...
Gastroenterology & Urology · 218d
Cleared Oct 30, 2025
Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
K252414 · OAP
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 90d
Cleared Oct 29, 2025
Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-,...
K253283 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 30d