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"
457–480 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Mar 28, 2023
Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D,...
K223928 · OHT
Shenzhen Fansizhe Science And...
General & Plastic Surgery · 88d
Cleared Mar 27, 2023
Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
K223882 · FTC
Shenzhen Honpal Optoelectronic...
General & Plastic Surgery · 90d
Cleared Mar 27, 2023
XT Stain/Glaze
K223192 · EIH
Shenzhen Xiangtong Co., Ltd.
Dental · 165d
Cleared Mar 24, 2023
Starly pad
K221589 · GXY
Shenzhen Xingyuanli Technology Co., Ltd.
Neurology · 296d
Cleared Mar 09, 2023
Electric breast pump (model: M5)
K223693 · HGX
Shenzhen Lutejiacheng Technology Co.,...
Obstetrics & Gynecology · 90d
Cleared Mar 03, 2023
Light Based Hair Removal Device GP592
K230060 · OHT
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 53d
Cleared Mar 02, 2023
1.5T 24E Posterior Array
K223203 · LNH
Shenzhen RF Tech Co., Ltd.
Radiology · 139d
Cleared Feb 28, 2023
IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06...
K223618 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 85d
Cleared Feb 26, 2023
Handheld Pulse Oximeter
K213431 · DQA
Shenzhen Witleaf Medical Electronics...
Anesthesiology · 493d
Cleared Feb 16, 2023
IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03
K223524 · OHT
Morlaser Shenzhen Co., Ltd.
General & Plastic Surgery · 85d
Cleared Feb 14, 2023
8ch T/R Knee Coil
K223225 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 119d
Cleared Feb 10, 2023
Glass Ceramic
K223194 · EIH
Shenzhen Xiangtong Co., Ltd.
Dental · 120d
Cleared Feb 09, 2023
External Drainage System
K221694 · JXG
Jmed(Shenzhen) Technology Limited
Neurology · 244d
Cleared Feb 07, 2023
Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp...
K222928 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 134d
Cleared Feb 03, 2023
GaiaBone Bioabsorbable Bone Graft
K220337 · MQV
Corliber (Shenzhen) Medical Device...
Orthopedic · 361d
Cleared Jan 19, 2023
Self-adhesive Electrode
K222252 · GXY
Shenzhen Roundwhale Technology Co. ,...
Neurology · 176d
Cleared Jan 19, 2023
Disposable Non-invasive EEG Sensor
K220448 · GXY
Shenzhen Med-Link Electronics Tech...
Neurology · 337d
Cleared Jan 19, 2023
Biosci™ Inactivated Transport Medium, Biosci™ ITM
K220059 · QBD
Shenzhen Dakewe Bio-Engineering Co.,...
Microbiology · 374d
Cleared Jan 04, 2023
Wearable Breast Pump (Model S1DW)
K222045 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 177d
Cleared Dec 30, 2022
Fingertip Pulse Oximeter
K213430 · DQA
Shenzhen Witleaf Medical Electronics...
Anesthesiology · 435d
Cleared Dec 29, 2022
Multi-Parameter Patient Monitor
K211619 · MHX
Shenzhen Comen Medical Instruments...
Cardiovascular · 582d
Cleared Dec 23, 2022
Leg Massager RF-ALM070
K222924 · IRP
Shenzhen Ruiyi Business Technology...
Physical Medicine · 88d
Cleared Dec 22, 2022
Air Compression Leg Massager (Model: LY-670D)
K222949 · IRP
Zhejiang Luyao Electronics Technology...
Physical Medicine · 86d
Cleared Dec 20, 2022
LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)
K221775 · OHS
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 182d