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"
601–624 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Dec 16, 2021
IPL hair removal machine
K213020 · OHT
Shenzhen Borria Technology Co., Ltd.
General & Plastic Surgery · 87d
Cleared Dec 15, 2021
Surgical Face Mask (Non-sterile)
K212398 · FXX
Hubei Kimsoul Industrial Co., Ltd.
General Hospital · 135d
Cleared Dec 13, 2021
Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
K211942 · NGX
Shenzhen Osto Technology Company Limited
Physical Medicine · 173d
Cleared Dec 10, 2021
Dental Scaler and Air Polisher
K203615 · ELC
Guilin Woodpecker Medical Instrument...
Dental · 365d
Cleared Dec 02, 2021
Clivia series Diagnostic Ultrasound System
K211886 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 164d
Cleared Dec 01, 2021
Electric Breast Pump
K211755 · HGX
Zhejiang Carebao Co., Ltd.
Obstetrics & Gynecology · 177d
Cleared Nov 22, 2021
Low-frequency Stimulator (Model: AST-645, AST-646)
K212989 · NUH
Shenzhen Osto Technology Co., Ltd.
Neurology · 63d
Cleared Nov 19, 2021
Leaf Smooth
K212697 · OHT
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Nov 18, 2021
Water-soluble Personal Lubricant
K212104 · NUC
Foshan Pingchuang Medical Technology...
Obstetrics & Gynecology · 135d
Cleared Nov 16, 2021
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound...
K212265 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 119d
Cleared Nov 16, 2021
Disposable Medical Nitrile Examination Gloves (non-sterile)
K212029 · LZA
Taizhou Kangjian Medical Equipments...
General Hospital · 140d
Cleared Nov 15, 2021
Air Compression Massager (Model LF-FT003)
K213000 · IRP
Wenzhou Lingfeng Electronic...
Physical Medicine · 56d
Cleared Nov 15, 2021
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K212765 · EIH
Bloomden Bioceramics (Hunan) Co., Ltd.
Dental · 76d
Cleared Nov 10, 2021
Venen-trainer (Model: FM150, SFM90)
K203746 · JOW
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 323d
Cleared Nov 07, 2021
Isolation Gown AAMI Level 3
K212504 · FYC
Kenpax International Limited
General Hospital · 90d
Cleared Nov 05, 2021
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic...
K212900 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 53d
Cleared Nov 05, 2021
Microcurrent device (Model: HBR2-1)
K211055 · NFO
Shenzhen DJ Medical Equipment Co., Ltd.
Neurology · 210d
Cleared Nov 04, 2021
IPL Hair Removal Device, model: AI01
K212897 · OHT
Shenzhen Century Dongyuan Technology...
General & Plastic Surgery · 55d
Cleared Nov 03, 2021
Fetal Doppler
K212084 · KNG
Shenzhen Mericonn Technology Co., Ltd.
Obstetrics & Gynecology · 124d
Cleared Nov 01, 2021
Electronic Blood Pressure Monitor
K212171 · DXN
Dongguan Kangweile Electronic...
Cardiovascular · 112d
Cleared Oct 26, 2021
Medical Diode Laser Systems
K211977 · GEX
Wuhan Dimed Laser Technology Co., Ltd.
General & Plastic Surgery · 123d
Cleared Oct 21, 2021
IPL Hair Removal Device
K212314 · OHT
Zhongshan Bisen Plastic Electronic...
General & Plastic Surgery · 90d
Cleared Oct 19, 2021
Sterile High-pressure Angiographic Syringes for Single-use
K211564 · DXT
Shenzhen Boon Medical Supply Co., Ltd.
General Hospital · 152d
Cleared Oct 15, 2021
Arm Blood Pressure Monitor
K210563 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 232d