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"
361–384 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Feb 12, 2024
EMS/TENS Massager Device
K233040 · NUH
Shenzhen Imdk Medical Technology Co.,...
Physical Medicine · 140d
Cleared Feb 08, 2024
XVbeam2000
K233914 · EHD
Shenzhen Xpectvision Technology Co.,...
Radiology · 58d
Cleared Feb 06, 2024
5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP,...
K233897 · PGY
Shenzhen Beacon Display Technology...
Radiology · 57d
Cleared Jan 31, 2024
Digital Thermometer, Model T28, T28L
K232678 · FLL
Guangdong Genial Technology Co., Ltd.
General Hospital · 152d
Cleared Jan 30, 2024
G-Vitri™ Vitrification Freeze Media
K232942 · MQL
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 132d
Cleared Jan 22, 2024
IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR,...
K233887 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 45d
Cleared Jan 22, 2024
Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G,...
K231423 · NUH
Shenzhen Roundwhale Technology Co. ,...
Neurology · 250d
Cleared Jan 19, 2024
Cold Compression Wrap Pro
K230524 · IRP
Chengdu Cryo-Push Medical Technology...
Physical Medicine · 326d
Cleared Jan 18, 2024
LuxCreo Dental Night Guard Resin
K230592 · MQC
LuxCreo, Inc.
Dental · 321d
Cleared Jan 12, 2024
LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)
K233114 · OHS
Shenzhen Idea Light Limited
General & Plastic Surgery · 107d
Cleared Jan 11, 2024
IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06...
K233664 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 57d
Cleared Jan 11, 2024
Neurological Therapy Devices - Accessories: Electrotherapy device Electrode...
K232995 · GXY
Shenzhen Roundwhale Technology Co. ,...
Neurology · 111d
Cleared Jan 08, 2024
Electronic Muscle Stimulator (Model MP01)
K233035 · NGX
Shenzhen Hengbosi Industrial Co., Ltd.
Neurology · 105d
Cleared Jan 07, 2024
Lifetech Cardio Temporary Pacemaker
K232721 · DTE
Shenzhen Lifetech Cardio Medical...
Cardiovascular · 124d
Cleared Jan 07, 2024
Teleport XT Microcatheter
K231608 · DQY
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 219d
Cleared Jan 05, 2024
IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04...
K233679 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 50d
Cleared Jan 04, 2024
LED Eye mask (EY-20R, A20, EY-20N)
K233556 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 59d
Cleared Dec 22, 2023
Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344,...
K232338 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 140d
Cleared Dec 21, 2023
Dental Glass Ceramics
K233016 · EIH
Shenzhen Yurucheng Dental Materials...
Dental · 90d
Cleared Dec 20, 2023
EMS Neck Massager
K233492 · NGX
Xiamen Comfier Technology Co., Ltd.
Neurology · 51d
Cleared Dec 16, 2023
Air Compression Recovery System
K233536 · IRP
Shenzhen Dongjilian Medical Tech Co.,...
Physical Medicine · 43d
Cleared Dec 15, 2023
IPL Hair Removal Device
K232939 · OHT
Shenzhen Borria Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Dec 14, 2023
Disposable Endobronchial Blocker Tube
K232580 · CBI
Shenzhen Insighters Medical...
Anesthesiology · 111d
Cleared Dec 13, 2023
Radiant Renewal Skincare Wand (HD-15, HD-15A)
K232863 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 89d