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"
1–24 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Jul 24, 2026
DiscreetDuo™ Flow Wearable Breast Pump (Model S3)
K260259 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 177d
Cleared Jul 23, 2026
FACEGYM Pro Device (HD-109)
K253932 · NFO
Shenzhen Kaiyan Medical Equipment...
Neurology · 226d
Cleared Jul 17, 2026
CHZL Red Light Therapy Hair Growth Cap...
K261675 · OAP
Shenzhen Chuanghong Zhilian...
General & Plastic Surgery · 57d
Cleared Jul 13, 2026
Wearable Breast Pump (Model S32A)
K261199 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 91d
Cleared Jun 26, 2026
TENS 7000 Rechargeable 4 Channel (TENS 7000H)
K260412 · NUH
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 137d
Cleared Jun 26, 2026
Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
K250070 · HGX
Shenzhen Changkun Technology Co., Ltd.
Obstetrics & Gynecology · 532d
Cleared Jun 25, 2026
Wearable breast pump (QY-101, QY-102, QY-108)
K261025 · HGX
Shenzhen Qinyi Electronic Technology...
Obstetrics & Gynecology · 87d
Cleared Jun 25, 2026
A5 Anesthesia System (A5)
K253330 · BSZ
Shenzhen Mindray Bio-Medical...
Anesthesiology · 268d
Cleared Jun 18, 2026
Pelvic Muscle Trainer (KM510, KM516B)
K260178 · KPI
Shenzhen Konmed Technology Co., Ltd.
Gastroenterology & Urology · 148d
Cleared Jun 18, 2026
Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)
K254254 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 171d
Cleared Jun 18, 2026
Wrist Blood Pressure Monitor (XW-05)
K253126 · DXN
Shenzhen Ziqing Medical Equipment...
Cardiovascular · 266d
Cleared Jun 17, 2026
Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )
K260538 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 120d
Cleared Jun 16, 2026
LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)
K254025 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 182d
Cleared Jun 15, 2026
Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte...
K253121 · MQE
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 263d
Cleared Jun 11, 2026
Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
K261256 · LXB
Shenzhen Magnet Technology Co., Ltd.
Ear, Nose, Throat · 56d
Cleared Jun 09, 2026
Mother's Nature W1 Warming Wearable Breast Pump
K260864 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 84d
Cleared Jun 03, 2026
VITA Multi-Function Head Brush (TB-2343F, TB-2442F)
K260179 · NFO
Touchbeauty Beauty & Health...
Neurology · 133d
Cleared Jun 03, 2026
Upper arm electronic blood pressure monitor (XB-01)
K253124 · DXN
Shenzhen Ziqing Medical Equipment...
Cardiovascular · 251d
Cleared May 29, 2026
Peak Flow Meter (PF-10(BR-PEF231))
K252802 · BZH
Shenzhen Bi-Rich Medical Devices Co.,...
Anesthesiology · 268d
Cleared May 26, 2026
Momcozy Nasal Aspirator (BN007)
K253629 · BTA
Shenzhen Root Innovation Technology...
Ear, Nose, Throat · 188d
Cleared May 21, 2026
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU,...
K261325 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 29d
Cleared May 21, 2026
Wearable Breast Pump (Model S39)
K254244 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 143d
Cleared May 20, 2026
IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG,...
K260594 · OHT
Shenzhen Xiazhifeng Electronic Co., Ltd.
General & Plastic Surgery · 86d
Cleared May 20, 2026
ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM...
K260098 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 127d