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"
337–360 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Apr 22, 2024
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona...
K240115 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 97d
Cleared Apr 12, 2024
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay...
K232587 · MRG
Shenzhen New Industries Biomedical...
Chemistry · 231d
Cleared Apr 10, 2024
Face Patches (MT-12MA, MT-12MC)
K240089 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 89d
Cleared Apr 05, 2024
Wrinkle Treatment Device (JM2)
K240360 · OHS
Shenzhen Qianyu Technology Co., Ltd.
General & Plastic Surgery · 59d
Cleared Apr 04, 2024
Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06...
K240652 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 28d
Cleared Apr 03, 2024
IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506,...
K240282 · OHT
Dongguan Boyuan Intelligent...
General & Plastic Surgery · 62d
Cleared Apr 03, 2024
Digital Thermometer
K230889 · FLL
Wenzhou Yosun Medical Technology Co.,Ltd
General Hospital · 369d
Cleared Mar 29, 2024
LCD Monitors C310S, G310S, C316S, G316S, C616W
K240310 · PGY
Shenzhen Beacon Display Technology...
Radiology · 56d
Cleared Mar 28, 2024
Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G,...
K240284 · IZL
Shenzhen Browiner Tech Co., Ltd.
Radiology · 56d
Cleared Mar 26, 2024
Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)
K231984 · DXN
Shenzhen Hingmed Medical Instrument...
Cardiovascular · 265d
Cleared Mar 20, 2024
Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008,...
K233901 · BTA
Shenzhen Desida Technology Co., Ltd.
Ear, Nose, Throat · 100d
Cleared Mar 19, 2024
Amydi-med Disposable Non-invasive EEG electrodes
K240668 · GXY
Shenzhen Amydi-Med Electrics Tech...
Neurology · 11d
Cleared Mar 19, 2024
Blood Pressure Monitor
K233146 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 174d
Cleared Mar 15, 2024
Wrist Blood Pressure Monitor (222)
K233799 · DXN
Shenzhen Yuezhongxing Technology Co.,...
Cardiovascular · 107d
Cleared Mar 08, 2024
Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A,...
K240264 · OHT
Shenzhen Mlay Intelligent Technology...
General & Plastic Surgery · 37d
Cleared Mar 06, 2024
Momcozy Wearable Breast Pump (BP137)
K233880 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 89d
Cleared Mar 06, 2024
Choledochoscope System
K231497 · FBN
Shenzhen HugeMed Medical Technical...
Gastroenterology & Urology · 287d
Cleared Mar 04, 2024
Vyvo
K231288 · DQA
Vyvo Technology Corp.(Vt)
Anesthesiology · 305d
Cleared Mar 01, 2024
Probe Covers (YF-001, YF-002)
K240023 · FLL
Shenzhen YI Fang Blister Packaging...
General Hospital · 58d
Cleared Mar 01, 2024
Muscle Stimulator
K231648 · NUH
Shenzhen Yiran Intelligent Co., Ltd.
Neurology · 270d
Cleared Feb 23, 2024
Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504,...
K233576 · KPI
Shenzhen Konmed Technology Co., Ltd.
Gastroenterology & Urology · 108d
Cleared Feb 20, 2024
Mjolnir Pro. (Multi–electrode plasma)
K233760 · QVJ
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 88d
Cleared Feb 16, 2024
Disposable Grounding Pad
K231985 · GEI
Shenzhen Mecun Medical Supply Co., Ltd.
General & Plastic Surgery · 226d
Cleared Feb 12, 2024
Facial Toning device (UIC-189)
K233667 · NFO
Body Trim Industrial Co., Ltd.
Neurology · 89d