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
Perpak Sterilization Tyvek Pouch
Km Corp.
Orthobond Mariner Pedicle Screw System
Orthobond Coporation
Assure Titanium Blood Glucose Monitoring System
Arkray, Inc.
truSculpt iD
Cutera, Inc.
Skin Clinic Nitro Clear Wart Remover
Cryoconcepts LP
PathBuilder Transseptal Guiding Introducer
Shanghai Microport EP Medtech Co., Ltd.
Luminopia One
Luminopia, Inc.
MICSI-RMT
Microstructure Imaging, Inc.
NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nP
Np Medical, Inc.
Genesys Spine Sacroiliac Joint Fusion System with Navigation
Genesys Spine
VITROS Immunodiagnostic Products CEA Reagent Pack
Ortho Clinical Diagnostics
PADLOCK CLIP EFTR Kit (00713229)
STERIS Corporation
Axial3D Insight
Axial Medical Printing Limited
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
Jeil Tech Co., Ltd.
ProLift Expandable Spacer System
Life Spine, Inc.
Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair R
Guangzhou Chuang Zao Mei Technology Co., Ltd.
eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)
Anker Innovations Limited
uMI Panvivo
Shanghai United Imaging Healthcare Co., Ltd.
Disposable Hot Biopsy Forceps
Beijing Zksk Technology Co., Ltd.
Yushan X-Ray Flat Panel Detector
Innocare Optoelectronics Corp.
FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix B
Prosidyan, Inc.
AQUA Laminoplasty Systems
ZheJiang Decans Medical Devices Co., Ltd.
LAP-iX2N
Sejong Medical Co., Ltd.
NIKKICART
Renal Care Dialysis Solutions, S.A. DE C.V.
SteriTite rigid reusable sterilization container with MediTray Products
Case Medical
V5med Lung AI
V5med, Inc.
Vial Adapter
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
Atellica CH Diazo Total Bilirubin (D_TBil)
Siemens Healthcare Diagnostics, Inc.
Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V
Olympus Medical Systems Corp.
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
Osteonic Co., Ltd.
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