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"
265–288 of 1,163
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Lead specialty: Cardiovascular
Cleared Nov 21, 2024
Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA,...
K232520 · DQA
Shenzhen Smallsignal Technology Co.,...
Anesthesiology · 461d
Cleared Nov 20, 2024
HIGHERDOSE Red Light Hat (HG-120K)
K242363 · OAP
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 103d
Cleared Nov 20, 2024
Leg Massager (Models:RP-ALM070H, RP-ALM071H)
K232965 · IRP
Shenzhen Ruiyi Business Technology...
Physical Medicine · 426d
Cleared Nov 19, 2024
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)
K242496 · IYO
Eieling Technology (Shenzhen) Limited
Radiology · 89d
Cleared Nov 18, 2024
Synxess Neurovascular Guidewire
K240871 · MOF
Enlight Medical Technologies...
Neurology · 234d
Cleared Nov 15, 2024
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G),...
K240523 · MQE
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology · 266d
Cleared Nov 14, 2024
Xrecovery (XR-001)
K242940 · IRP
Shenzhen Xinrun Electric Appliances...
Physical Medicine · 50d
Cleared Nov 08, 2024
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona...
K242231 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 101d
Cleared Nov 08, 2024
Hair Growth Comb (SZ-23,SZ-23A)
K241342 · OAP
Shenzhen Nuon Medical Equipment Co.,...
General & Plastic Surgery · 179d
Cleared Nov 07, 2024
Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
K242595 · OHT
Shenzhen Greatro Electronic...
General & Plastic Surgery · 69d
Cleared Nov 06, 2024
Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB,...
K242039 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 117d
Cleared Nov 05, 2024
Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341,...
K242332 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 90d
Cleared Nov 01, 2024
Breo Laser Hair Growth Comb (Scalp 3L)
K242620 · OAP
Shenzhen Breo Technology Co., Ltd.
General & Plastic Surgery · 59d
Cleared Oct 31, 2024
Disposable Blood Pressure cuff
K242623 · DXQ
Shenzhen Medke Technology Co., Ltd.
Cardiovascular · 58d
Cleared Oct 31, 2024
V80 Anesthetic Vaporizer (V80)
K240375 · CAD
Shenzhen Mindray Bio-Medical...
Anesthesiology · 267d
Cleared Oct 28, 2024
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
K241718 · OHS
Shenzhen Aozemei Technology Co., Ltd.
General & Plastic Surgery · 136d
Cleared Oct 25, 2024
LCD Monitors C310S, G310S, C316S, G316S, C616W
K243031 · PGY
Shenzhen Beacon Display Technology...
Radiology · 28d
Cleared Oct 25, 2024
Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302,...
K240092 · DQA
Shenzhen Yimi Life-Technology Co., Ltd.
Anesthesiology · 287d
Cleared Oct 24, 2024
Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)
K241554 · IYN
Telefield Medical Imaging (Shenzhen)...
Radiology · 146d
Cleared Oct 24, 2024
Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
K241007 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 195d
Cleared Oct 17, 2024
IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)
K242197 · OHT
Shenzhen Huaruibo Electric Appliances...
General & Plastic Surgery · 83d
Cleared Oct 16, 2024
Safe Secure Sterilization Pouches and Rolls
K242839 · FRG
Shenzhen Safesecure Medical Infection...
General Hospital · 27d
Cleared Oct 16, 2024
Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205,...
K241613 · DXN
Shenzhen Hbcare Technology Co.,Ltd
Cardiovascular · 133d
Cleared Oct 15, 2024
Denture Base Resin (PN-Denture (Red, White))
K241673 · EBF
Shenzhen Piocreat 3D Technology Co.,...
Dental · 126d