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
TopCEM-Veneer Light Cure Veneer Cement
Rizhao Huge Biomaterials Company, Ltd.
Bonvadis®
Oneness Biotech Co., Ltd.
BlueStar Rx
Welldoc, Inc.
Klox Biophotonic LumiHeal System
Klox Technlogies, Inc.
Cleaner Plus Thrombectomy System
Argon Medical Devices, Inc.
PediGuard Threaded
Spineguard S.A.
Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Smart Glove Corporation Sdn. Bhd.
Nightwear Aligners
Smylio, Inc.
Sonopet iQ Ultrasonic Aspirator System
Stryker Corporation
Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization De
Rapid Medical , Ltd.
SDS Growing Rod
BAAT Medical Products B.V.
Probe Covers (YF-001, YF-002)
Shenzhen YI Fang Blister Packaging Co., Ltd.
EXA
Konica Minolta Healthcare Americas, Inc.
AT
At Glove Engineering Sdn. Bhd
InMode RF System
InMode , Ltd.
Nitrile Gloves (Model: NE01)
Byd Auto Industry Company Limited
Neurophet SCALE PET
Neurophet., Inc.
1.5T 24E Posterior Array
Shenzhen RF Tech Co., Ltd.
SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System
SeaSpine Orthopedics Corporation
DTX Studio Clinic (4.0)
Nobel Biocare AB
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
Safesource Direct, LLC
Parietene Macroporous Mesh (PPM5050 )
Sofradim Production
Sterile Syringes for Single Use
Shanghai Kindly Enterprise Development Group Co., Ltd.
Disposable Surgical Face Mask
Efofex, Inc.
Kerecis SurgiBind (50241)
Kerecis Limited
Current Health Monitoring System Gen 2 (G2)
Current Health
HemoCare Bicarbonate Concentrate Set (BCS)
Deka Research and Development
Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
Neurosigma, Inc.
Puravita Medical Fold Flat Surgical Mask
Puravita M, LLC
Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U10
Unimed Medical Supplies, Inc.
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