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"
481–504 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Dec 20, 2022
Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E,...
K221039 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 257d
Cleared Dec 16, 2022
Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)
K213984 · DQA
Shenzhen Zhengkang Technology Co., Ltd.
Anesthesiology · 361d
Cleared Dec 15, 2022
VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor
K221267 · MWI
Shenzhen Mindray Bio-Meidcal...
Cardiovascular · 227d
Cleared Dec 13, 2022
Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer...
K220046 · DJG
Shenzhen Superbio Technology Co., Ltd.
Toxicology · 342d
Cleared Dec 08, 2022
8ch Wrist Coil
K223239 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 49d
Cleared Dec 06, 2022
Dental Zirconia Ceramic
K222626 · EIH
Aidite (Qinhuangdao) Technology Co.,...
Dental · 97d
Cleared Dec 05, 2022
Cryopush Cold Compression Device
K222669 · IRP
Chengdu Cryo-Push Medical Technology...
Physical Medicine · 90d
Cleared Dec 02, 2022
Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor
K221113 · MWI
Shenzhen Mindray Bio-Medical...
Cardiovascular · 231d
Cleared Dec 01, 2022
IPL Cooling Hair Removal Device
K222710 · OHT
Shenzhen Siken 3D Technology...
General & Plastic Surgery · 84d
Cleared Dec 01, 2022
Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D,...
K222125 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 136d
Cleared Nov 22, 2022
LED Light Therapy Mask (model: MK66R-B)
K221946 · OHS
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 140d
Cleared Nov 21, 2022
Implanter incl. Accessories
K211358 · EBW
Guilin Woodpecker Medical Instrument...
Dental · 567d
Cleared Nov 17, 2022
IPL Hair Removal Device
K222598 · OHT
Shenzhen Noble Smart Manufacturing...
General & Plastic Surgery · 80d
Cleared Nov 17, 2022
Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
K212910 · EFB
Shenzhen Carejoy Technology Co., Ltd.
Dental · 430d
Cleared Nov 09, 2022
ViewMate Multi Ultrasound System
K222754 · IYN
Shenzhen Mindray Bio-Meidcal...
Radiology · 58d
Cleared Nov 08, 2022
Oxyfit Pulse Oximeter
K203812 · DQA
Shenzhen Viatom Technology Co., Ltd.
Anesthesiology · 680d
Cleared Nov 07, 2022
Vericor Support Catheter
K222679 · KRA
Vascupatent Medical (Shenzhen) Co., Ltd.
Cardiovascular · 62d
Cleared Oct 28, 2022
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
K214109 · GXN
Kontour(Xi?An) Medical Technology...
Neurology · 303d
Cleared Oct 21, 2022
Hair Removal Device (Model: IPL-D26, IPL-D19)
K221643 · OHT
Shenzhen Desida Technology Co., Ltd.
General & Plastic Surgery · 137d
Cleared Oct 20, 2022
Electric nasal aspirator
K222547 · BTA
Shenzhen Xinlianfeng Technology Co.,Ltd
Ear, Nose, Throat · 58d
Cleared Oct 16, 2022
Pulse Oximeter (Model C101A2, C101B1, C101A3)
K221979 · DQA
Shenzhen Imdk Medical Technology Co.,...
Anesthesiology · 103d
Cleared Oct 14, 2022
IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
K222537 · OHT
Shenzhen Ishine Technology Company...
General & Plastic Surgery · 53d
Cleared Oct 12, 2022
Arm Blood Pressure Monitor
K221913 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 104d
Cleared Oct 11, 2022
Surgical Mask
K222335 · FXX
Luoyang Sunmed Devices Co., Ltd.
General Hospital · 69d