510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
Digital Flat Panel Detector
Ray Imaging Technology (Haining) Limited
Verge Microcatheter
Instylla, Inc.
Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)
Yuwonmeditech Co., Ltd.
Suture Wing
Osteonic Co., Ltd.
Digital Prism Correction Feature (DPCF)
Apple, Inc.
PatCom Distal Chip Endoscope
H&A Mui Enterprises, Inc.
Inno-Port Disposable Bladed Trocar
Taiwan Surgical Corporation
Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)
Wuhan Pioon Technology Co., Ltd.
MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption
Tonica Elektronik A/S
FFX Facet Fixation System
Sc Medica
Percutaneous Nephroscope System
Karl Storz SE & CO. KG
Easi-Vue® embolic microspheres System
Abk Biomedical, Inc.
Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel
Cardinalhealth
Custom Stable Rigid Gas Permeable Scleral Contact Lens
Valley Contax, Inc.
Skin Clinic Freeze Point for Warts and Skin Tags
Cryoconcepts LP
Intravascular Extension Sets and Accessories
Baxter Healthcare Corporation
LineSider® Spinal System
Integrity Implants, Inc.
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20
Shenzhen Ulike Smart Electronics Co., Ltd.
Yomi Robotic System
Neocis, Inc.
Foundation Dermal Regeneration Scaffold (DRS) Solo
Bionova Medical, Inc.
Capsule Surveillance System
Capsule Surveillance Technologies, Sas /Capsule Tech, Inc.
Ultrasound Stimulator
Jkh Health Co., Ltd.
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
ETHICON, Inc.
Mercu 1717V
Iray Technology Taicang , Ltd.
Identify (4.0)
Varian Medical Systems, Inc.
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
Splintek, Inc.
Dental diode laser, SOGA Laser, ILaser II
Shenzhen Soga Technology Co., Ltd.
Carnation Ambulatory Monitor
Bardy Diagnostics, Inc.
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
Sienco, Inc.
da Vinci SP Firefly Imaging System
Intuitive Surgical, Inc.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert