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"
25–48 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared May 20, 2026
Blood Pressure Monitor (W06LT)
K253570 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 184d
Cleared May 19, 2026
SOGA Lasers therapy system family of Aurora handpiece (Aurora-S)
K253309 · NVK
Shenzhen Soga Technology Co., Ltd.
Dental · 232d
Cleared May 15, 2026
Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02
K260134 · BTA
Shenzhen Root Innovation Technology...
Ear, Nose, Throat · 119d
Cleared May 14, 2026
Suction Pump (SU-90)
K260892 · BTA
Shenzhen HugeMed Medical Technical...
General & Plastic Surgery · 57d
Cleared May 14, 2026
Palmtop Ultrasound Diagnostic System (MT10P/MT10)
K260111 · IYN
Mytech Intelligence (Shenzhen) Co., Ltd.
Radiology · 120d
Cleared May 14, 2026
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M,...
K254048 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 148d
Cleared May 12, 2026
Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
K260473 · BTA
Shenzhen Kingboom Technology Co., Ltd.
Ear, Nose, Throat · 89d
Cleared May 11, 2026
Diagnostic Ultrasound System (MU9)
K260846 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 56d
Cleared May 11, 2026
Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO,...
K252655 · DQA
Shenzhen Imdk Medical Technology Co.,...
Anesthesiology · 262d
Cleared May 06, 2026
Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
K252552 · KPI
Shenzhen Changkun Technology Co., Ltd.
Gastroenterology & Urology · 266d
Cleared May 05, 2026
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP,...
K260742 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 60d
Cleared May 05, 2026
Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1,...
K254200 · IRP
Wenzhou Lingfeng Electronic...
Physical Medicine · 127d
Cleared May 04, 2026
Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)
K260688 · OLI
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 62d
Cleared Apr 29, 2026
Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C,...
K253914 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 142d
Cleared Apr 22, 2026
LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)
K260150 · OHS
NOOANCE
General & Plastic Surgery · 92d
Cleared Apr 21, 2026
IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371,...
K260518 · OHT
Shenzhen Semlamp Intelligent...
General & Plastic Surgery · 63d
Cleared Apr 16, 2026
uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
K253170 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 202d
Cleared Apr 16, 2026
High Pressure Syringe
K253048 · DXT
Shenzhen Maiwei Biotech Co., Ltd.
General Hospital · 206d
Cleared Apr 15, 2026
Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
K260129 · OLI
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 89d
Cleared Apr 14, 2026
Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
K253107 · BTA
Shenzhen Dongjiang Technology Co., Ltd.
Ear, Nose, Throat · 202d
Cleared Apr 14, 2026
HD 8Ch Wrist Array
K252587 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 242d
Cleared Apr 10, 2026
Teleport Glide Microcatheter
K253361 · DQY
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 192d
Cleared Apr 08, 2026
Wearable Breast Pump (Model S21A)
K260033 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 92d
Cleared Apr 08, 2026
Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D,...
K254258 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 100d