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"
433–456 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Jun 16, 2023
Fitness Belt (Model: KLT-07)
K231136 · NGX
Shenzhen Kelutongda Industrial Co., Ltd.
Physical Medicine · 56d
Cleared Jun 16, 2023
Mindray SV600 Ventilator, Mindray SV800 Ventilator
K220107 · CBK
Shenzhen Mindray Bio-Medical...
Anesthesiology · 520d
Cleared Jun 15, 2023
IPL Hair Removal Device Models: MLY-T069
K230473 · OHT
Miley Technology (Hebei) Co., Ltd.
General & Plastic Surgery · 113d
Cleared Jun 14, 2023
Electronic Blood Pressure Monitor
K223291 · DXN
Shenzhen Pango Medical Electronics...
Cardiovascular · 231d
Cleared Jun 09, 2023
Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)
K230776 · HGX
Shenzhen Lutejiacheng Technology Co.,...
Obstetrics & Gynecology · 80d
Cleared Jun 09, 2023
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9...
K230768 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 81d
Cleared Jun 07, 2023
Infrared Thermometer
K222248 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 316d
Cleared May 26, 2023
Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608,...
K230739 · OHT
Shenzhen Ionka Medical Technology...
General & Plastic Surgery · 70d
Cleared May 25, 2023
Soreal Press, Soreal CAD
K230259 · EIH
Shenzhen Up3D Technology Co., Ltd.
Dental · 114d
Cleared May 10, 2023
Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032,...
K222870 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 230d
Cleared May 09, 2023
Tens & Ems Device
K223825 · NUH
Shenzhen Jian Feng Electronic...
Physical Medicine · 139d
Cleared May 08, 2023
Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A,...
K223428 · NUH
Shenzhen Leqing Medical Instrument...
Neurology · 175d
Cleared May 05, 2023
LED Facial Mask
K230351 · OHS
Shenzhen Sungpo Hi-Tech Electronic...
General & Plastic Surgery · 85d
Cleared May 05, 2023
Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model...
K222926 · DXN
Shenzhen Yuezhongxing Technology Co.,...
Cardiovascular · 221d
Cleared May 04, 2023
Finger Pulse Oximeter, Model: X1906P
K221798 · DQA
Shenzhen Changkun Technology Co., Ltd.
Anesthesiology · 317d
Cleared Apr 26, 2023
Endo Motor
K222548 · EKX
Shenzhen Perfect Medical Instruments...
Dental · 246d
Cleared Apr 25, 2023
IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL,...
K230549 · OHT
Shenzhen Xiazhifeng Electronic Co., Ltd.
General & Plastic Surgery · 56d
Cleared Apr 11, 2023
Bronchoscope System
K222910 · EOQ
Shenzhen HugeMed Medical Technical...
Ear, Nose, Throat · 197d
Cleared Apr 10, 2023
IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02
K230360 · OHT
Shenzhen Jizhimei Technology Co., Ltd.
General & Plastic Surgery · 59d
Cleared Apr 10, 2023
IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
K230122 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 83d
Cleared Apr 06, 2023
IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105,...
K230097 · OHT
Shenzhen Bsx Technology Electronics...
General & Plastic Surgery · 83d
Cleared Apr 05, 2023
BioSci™ Disposable Virus Sampling Tubes
K230035 · JSM
Shenzhen Dakewe Bio-Engineering Co.,...
Microbiology · 90d
Cleared Mar 31, 2023
BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug...
K230238 · DJG
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 60d
Cleared Mar 31, 2023
IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32
K230021 · OHT
Shenzhen Yangyi Technology ., Ltd.
General & Plastic Surgery · 86d