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"
577–600 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Feb 18, 2022
Zirconia Dental Ceramics
K214005 · EIH
Shenzhen Yurucheng Dental Materials...
Dental · 59d
Cleared Feb 18, 2022
Dental Zirconia Pre-shaded Block
K214003 · EIH
Shenzhen Yurucheng Dental Materials...
Dental · 59d
Cleared Feb 18, 2022
Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E
K213503 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 109d
Cleared Feb 18, 2022
Ear Thermometer, Model ET001
K213079 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 148d
Cleared Feb 17, 2022
Digital Intraoral X-ray Sensor
K220277 · MUH
Shenzhen Xpectvision Technology Co.,...
Radiology · 17d
Cleared Feb 17, 2022
TENS & PMS (Model: SM9126)
K220150 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 29d
Cleared Feb 17, 2022
Safety Pen Needle
K210864 · FMI
Sandstone Medical (Suzhou), Inc.
General Hospital · 331d
Cleared Feb 11, 2022
Wearable Breast Pump (Model S12)
K212180 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 214d
Cleared Feb 01, 2022
VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
K212410 · MQL
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology · 182d
Cleared Jan 28, 2022
Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311
K213082 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 127d
Cleared Jan 20, 2022
Electric breast pump
K212884 · HGX
Dongguan Rongfeng Medical Co., Ltd.
Obstetrics & Gynecology · 132d
Cleared Jan 19, 2022
LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.
K213447 · OAP
Shenzhen Cosbeauty Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Jan 14, 2022
IPL Hair Removal
K212318 · OHT
Dongguan Define Beauty Electronic...
General & Plastic Surgery · 172d
Cleared Jan 14, 2022
Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100,...
K211632 · DQA
Shenzhen Narig Bio-Medical Technology...
Anesthesiology · 232d
Cleared Jan 13, 2022
Dental Electric Motor
K203706 · EBW
Guilin Woodpecker Medical Instrument...
Dental · 391d
Cleared Jan 12, 2022
Arm Blood Pressure Monitor
K212877 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 125d
Cleared Jan 07, 2022
Fetal Doppler
K211940 · KNG
Shenzhen Taikang Medical Equipment...
Obstetrics & Gynecology · 198d
Cleared Jan 07, 2022
Infrared Thermometer
K210564 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 316d
Cleared Dec 22, 2021
Diode Laser System GP900A8, Diode Laser System GP900Q8
K213225 · GEX
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 84d
Cleared Dec 22, 2021
Oren LED Perioral Light Therapy System
K213024 · OHS
Shenzhen Kaiyan Medical CO , Ltd.
General & Plastic Surgery · 92d
Cleared Dec 22, 2021
Pulse Oximeter
K210305 · DQA
Dongguan Lingxin Technologies Co., Ltd.
Anesthesiology · 322d
Cleared Dec 20, 2021
Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)
K211750 · FXX
National Bridge Industrial (S.Z.)...
General Hospital · 196d
Cleared Dec 20, 2021
IPL Home Use Hair Removal Device
K211185 · OHT
Shenzhen Beauty Every Moment...
General & Plastic Surgery · 244d
Cleared Dec 17, 2021
Cordless Prophy System, Model: i-Polish
K211531 · EKX
Guilin Woodpecker Medical Instrument...
Dental · 214d