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
G-EYE System
Smart Medical Systems , Ltd.
HARBOR Occlusion Device
Nuvascular, Inc.
CD Horizon Spinal System
Medtronic Sofamor Danek USA, Inc.
Dakota ALIF Plate System
Precision Spine, Inc.
ARROW Short Stem Humeral System
FH Industrie
PTG-05
Zimmer Medizinsysteme GmbH
Endoform Dental Membrane
Aroa Biosurgery , Ltd.
Venus Nova (FP-2001)
Venus Concept, Inc.
NanoDrop Lancet
Drawbridge Health, Inc.
Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable
CathRx, Ltd.
Nitrile Examination Gloves
Emerald Glove Manufacturing Sdn Bhd
Sunsphere
Hangzhou Yangshun Medical Technology Co.,Ltd
Senographe Pristina
GE Healthcare
Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
Shenzhen Kentro Medical Electronics Co., Ltd.
BriefCase-Triage
Aidoc Medical , Ltd.
Cystoscope System
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Simparo Anchor Line Fixation System
Simparo, Inc.
Vision Monitor - MonpackONE
Metrovision
Planmeca Viso
Planmeca Oy
Welspun Health Surgical Mask
Welspun India Limited
Braun Skin i.expert
Cyden Limited
SINC Support Catheter
Reflow Medical, Inc.
Neodent Implant System - Helix Short Surgical Kit Cases
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Okti
Compumedics Limited
SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System
Lima Corporate S.P.A.
Arthrex Knotless FiberTak Suture Anchor
Arthrex, Inc.
KYPHON VuE Bone Cement
Tecres S.P.A.
CloudPoint FastDesign Chairside
Prismatik Dentalcraft, Inc.
GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System
Greens Surgicals Pvt. , Ltd.
Dental Glass Ceramics
Shenzhen Yurucheng Dental Materials Co., Ltd.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert