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
Electrically Powered Wheelchair (Model YC-01)
Yurob Rehabilitation Medical Co., Ltd.
Endura Ureteral Stent and Stent Set
Cathegenix (Xiamen) Co., Ltd.
Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)
Gigaalaser Company , Ltd.
EndoTool SubQ 2.1
Monarch Medical Technologies, LLC
LuxCreo Clear Aligner System
LuxCreo, Inc.
ALIGN Radial Head System
Skeletal Dynamics, Inc.
Vy Spine ClariVy Cervical IBF System
Vy Spine, LLC
Cionic Neural Sleeve NS-100
Cionic
Electrically Powered Wheelchair
Kunshan Hi-Fortune Health Products Co., Ltd.
IPL Home Use Hair Removal Device
Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.
Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherap
Yty Industry (Manjung) Sdn Bhd
Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)
Shenzhen Root Innovation Technology Co., Ltd.
Epildream HP 4000 MED
D.E.A Project S.R.1.
Picocaremajesty
Wontech Co., Ltd.
MagnetOs MIS
Kuros Biosciences B.V
Spineology Navigation Instruments
Spineology, Inc.
Anchor with Fiber Wire and Disposable Inserter
Ortobio S.A.
Saffron Fixation System
Coloplast A/S
Accuray Precision Treatment Planning System
Accuray Incorporated
Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl
Zibo Lanhua Medical Packaging Material Co., Ltd.
DentCare Aligners
Dentcare Dental Lab Pvt , Ltd.
WHILL Model F
Whill, Inc.
XD
Mirada Medical, Ltd.
DOC Band 3D
Cranial Technologies, Inc.
Coresculpt & Magsculpt
K1Med Co., Ltd.
Compremium Compartment Compressibility Monitoring System (CPM#1)
Compremium AG
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture ancho
Suzhou Endophix Co., Ltd.
Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup
Vivachek Biotech (Hangzhou) Co., Ltd.
Newclip Patient-matched instrumentation non sterile PSI
Newclip Technics
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