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"
505–528 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Oct 07, 2022
Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105,...
K221170 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 168d
Cleared Sep 30, 2022
Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)
K222206 · IRP
Shenzhen Dongjilian Medical Tech Co.,...
Physical Medicine · 67d
Cleared Sep 30, 2022
Unscented Menstrual Tampon
K222046 · HEB
Suzhou Borage Medical Technology Co.,...
Obstetrics & Gynecology · 81d
Cleared Sep 29, 2022
Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S,...
K221496 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 129d
Cleared Sep 29, 2022
Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S,...
K221300 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 147d
Cleared Sep 28, 2022
IPL Hair Removal Device
K222316 · OHT
Shenzhen Goodwind Technology...
General & Plastic Surgery · 57d
Cleared Sep 27, 2022
Infrared thermometer
K221211 · FLL
Shenzhen Yolanda Technology Co., Ltd.
General Hospital · 153d
Cleared Sep 22, 2022
Disposable Polyp Snare
K220089 · FDI
Jiangsu Vedkang Medical Science and...
Gastroenterology & Urology · 254d
Cleared Sep 21, 2022
Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608,...
K221214 · ONF
Shenzhen Ionka Medical Technology...
General & Plastic Surgery · 147d
Cleared Sep 13, 2022
Transcutaneous Electrical Nerve Stimulator Model: ST-304
K221092 · NUH
Shenzhen Future Electronic Co., Ltd.
Neurology · 153d
Cleared Sep 08, 2022
BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens
K220143 · LPL
Shenzhen Dashicheng Optical...
Ophthalmic · 233d
Cleared Sep 07, 2022
Matreneu Percutaneous Balloon Compression Kit
K220920 · HAO
Shenzhen Shineyard Medical Device Co....
Neurology · 161d
Cleared Aug 31, 2022
IPL sapphire ice cooling hair remove device
K221635 · OHT
Shenzhen Desida Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Aug 29, 2022
Blood Pressure Monitor
K220676 · DXN
Guangdong Transtek Medical...
Cardiovascular · 174d
Cleared Aug 26, 2022
Upper Arm Blood Pressure Monitor
K221212 · DXN
Shenzhen Yolanda Technology Co., Ltd.
Cardiovascular · 121d
Cleared Aug 24, 2022
Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
K220998 · NUH
Shenzhen Kentro Medical Electronics...
Physical Medicine · 142d
Cleared Aug 18, 2022
iClean Viral Transport System (VTM-RT kit)
K212856 · JSM
Huachenyang (Shenzhen) Technology Co....
Microbiology · 344d
Cleared Aug 16, 2022
Clear Aligner
K213026 · NXC
Shenzhen Meiming Dentistry Technology...
Dental · 329d
Cleared Aug 12, 2022
IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17
K221466 · OHT
Shenzhen Century Dongyuan Technology...
General & Plastic Surgery · 85d
Cleared Aug 01, 2022
IPL hair removal
K221451 · OHT
Shenzhen Lizbella Technology Co.,Ltd
General & Plastic Surgery · 75d
Cleared Jul 27, 2022
Upper Arm Type Blood Pressure Monitor
K220886 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 121d
Cleared Jul 26, 2022
LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
K221567 · PGY
Qingdao Hisense Medical Equipment...
Radiology · 56d
Cleared Jul 20, 2022
Biofeedback Nerve and Muscle Stimulator
K220161 · KPI
Shenzhen Konmed Technology Co., Ltd.
Gastroenterology & Urology · 181d
Cleared Jul 12, 2022
N Series Patient Monitors
K213799 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 218d