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
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elit
Boston Scientific Corporation
Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)
Nemoto Kyorindo Co., Ltd.
Tiger 2 System
Zavation Medical Products, LLC
Nitrile Examination Gloves
Wuhan Huirui Technology Co., Ltd.
WavelinQ Generator
C.R. Bard, Inc.
Disposable Nitrile Examination Gloves
Chifeng Huawei Medical Science&Technology Co., Ltd.
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
Depuy Ireland UC
YUWELL Electronic Blood Pressure Monitor
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20
Shenzhen Smallsignal Technology Co., Ltd.
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
Inomed Medizintechnik GmbH
PlanOne 1
Cosylab Jsc, Control System Laboratory
Oligio X
Wontech Co., Ltd.
Synthetic Nitrile Examination Gloves
Shandong Hongxin Chemicals Co., Ltd.
DuraGraft
Marizyme, Inc.
Masimo W1
Masimo Corporation
Patriot-SI Posterior Implant System
Spinal Simplicity, LLC
16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)
Quality Electrodynamics
OdneClean
Odne AG
syngo Application Software
Siemens Medical Solutions USA, Inc.
Neodent Implant System - GM Zygomatic Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.
G-BLOCK
Graphenano Dental S.L.
C&B 5.0 Hybrid
Arum Dentistry Co., Ltd.
Equinoxe® Shoulder System
Exactech, Inc.
SpineAR SNAP
Surgical Theater, Inc.
Allograft Delivery Device (OFAC-C)
Bioventus, LLC
Visby Medical Sexual Health Test
Visby Medical
BAROguard
Paragonix Technologies
Cios Select (VA21) Flat Panel
Siemens Medical Solutions USA, Inc.
Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)
Pt. Universal Gloves
Avara Viewer
Avara Software
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