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
Disposable Medical Nitrile Examination Gloves (Non-sterile)
Suqian Linglian Medical Technology Co., Ltd.
Medical Surgical Mask (Planar type)
Hunan Chopard Medical Devices Co., Ltd.
FIREFLY® Pedicle Screw Navigation Guide
Mighty Oak Medical
Voluson SWIFT; Voluson SWIFT+
Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC
OncoMate MSI Dx Analysis System
Promega Corporation
Altus Spine Navigation System
Altus Partners, LLC
BENCOX Mirabo Z Cup Cortinium
Corentec Co., Ltd.
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM & BALTEUM-ONE Lumbar Plate
K&J Consulting Corp.
3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M
3M Company
Altaviz Intravitreal Syringe
Altaviz, LLC
Multi-Functional Electrosurgical Knife
Anrei Medical (Hangzhou) Co., Ltd.
Rapid Neuro3D
Ischemaview, Inc.
Premier Resolution System
Trinity Biotech (Primus Corporation, Dba Trinity Biotech)
TeleRehab Aermos Cardiopulmonary Rehabilitation
The ScottCare Corporation
LimFlow Vector
LimFlow, Inc.
UltraCor Twirl Breast Tissue Marker
Bard Peripheral Vascular, Inc.
PMW01 Procedure Mask Level 1
Defender Safety, Inc.
Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)
Iq Endoscopes Limited
Copra Supreme
Whitepeaks Dental Solutions GmbH
PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
Primus Sterilizer Company, LLC
Facet 28G Universal Lancet
Facet Technologies, LLC
Lancing device (HH-XV-T)
Tianjin Huahong Technology Co., Ltd.
Q Pedicle Instruments
K2m, Inc.
Disposable Medical Mask
Guangzhou Fuzelong Hygiene Material Co., Ltd.
Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
Oxoid Limited (Part of Thermo Fisher Scientific)
Idys® LIF
Clariance
MonoStereo
Medicaltek Co., Ltd.
Eyer 2
Phelcom Technologies
Esthetic Colorant
Kuraray Noritake Dental, Inc.
Access anti-HAV IgM
Beckman Coulter, Inc.
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