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"
649–672 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Jul 14, 2021
Aduro Light Beauty Mask
K202390 · OHS
Shenzhen Kaiyan Medical CO , Ltd.
General & Plastic Surgery · 327d
Cleared Jul 08, 2021
Nerve and Muscle Stimulator
K211094 · IPF
Shenzhen Xft Medical Limited
Physical Medicine · 87d
Cleared Jul 08, 2021
Nebulizer Kit
K192971 · CAF
Excellentcare Medical (Huizhou) , Ltd.
Anesthesiology · 624d
Cleared Jul 07, 2021
Infrared Forehead Thermometer
K202741 · FLL
Shenzhen Combei Technology Co., Ltd.
General Hospital · 292d
Cleared Jul 01, 2021
DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
K211337 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 59d
Cleared Jun 17, 2021
Migraine Tens Digital Pain Reliever
K210364 · PCC
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 129d
Cleared Jun 17, 2021
Infrared Thermometer
K202440 · FLL
Shenzhen Sonida Digital Technology...
General Hospital · 296d
Cleared Jun 14, 2021
Ultrasonic Mesh Nebulizer
K201397 · CAF
Shenzhen Ivankaca Technology Co., Ltd.
Anesthesiology · 382d
Cleared Jun 11, 2021
Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H
K210756 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 88d
Cleared Jun 10, 2021
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9...
K210699 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 93d
Cleared Jun 10, 2021
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9...
K210416 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 119d
Cleared Jun 08, 2021
Disposable Surgical Mask
K202126 · FXX
Shenzhen Peninsula Medical Co., Ltd.
General Hospital · 312d
Cleared Jun 07, 2021
Disposable Surgical Mask
K210372 · FXX
Dongguan Shin YI Healthcare Products...
General Hospital · 119d
Cleared Jun 02, 2021
Surgical Face Mask
K203190 · FXX
Rfx+Care Manufactoring Co., Ltd.
General Hospital · 218d
Cleared May 21, 2021
IPL Hair Removal Device (Model: KCA423)
K210119 · ONF
Shenzhen Boyuan Intelligent...
General & Plastic Surgery · 122d
Cleared May 19, 2021
TENS & EMS Device
K202866 · NUH
Shenzhen Jian Feng Electronic...
Physical Medicine · 233d
Cleared May 18, 2021
Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges
K202709 · GDW
Ningbo Verykind Medical Device Co., Ltd.
General & Plastic Surgery · 244d
Cleared May 12, 2021
Automatic Arm Electronic Blood Pressure Monitor
K210435 · DXN
Shenzhen Lepu Intelligent Medical...
Cardiovascular · 89d
Cleared May 06, 2021
Umbilical Vessels Catheter
K201697 · FOS
Haolang Medical USA Corporation
General Hospital · 318d
Cleared Apr 28, 2021
Medical Mask
K210020 · FXX
Zhende Medical Co., Ltd.
General Hospital · 114d
Cleared Apr 23, 2021
Pulse Oximeter
K203854 · DQA
Shenzhen Hexin Zondan Medical...
Anesthesiology · 113d
Cleared Apr 21, 2021
Disposable medical surgical mask
K202759 · FXX
Chongqing Coe Display Technology Co.,...
General Hospital · 212d
Cleared Apr 16, 2021
Infrared Thermometer Models: DT-8806S, DT-8807S
K203170 · FLL
Shenzhen Everbest Machinery Industry...
General Hospital · 175d
Cleared Apr 11, 2021
Disposable Medical Mask
K210018 · FXX
Diasia Biomedical Technology Co., Ltd.
General Hospital · 97d