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
Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)
Church & Dwight Co., Inc.
Oxygen Concentrator (J5A)
Foshan Kycare Medical Equipment Co., Ltd.
True Non-Surgical Spinal Decompression System (DRX9000-SL)
Excite Medical of Tampa Bay, LLC
CATS-L Tonometer Prism
Cats Tonometer, LLC
VITA YZ Multi Translucent
Vita Zahnfabrik H.Rauter GmbH & Co.
RAYSCAN a-Expert3D
Ray Co., Ltd.
Pearl Clear Aligner
Pearl Digital, Inc.
Tigertriever 25 Revascularization Device
Rapid Medical Ltd.
HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))
Gentuity, LLC
myAir
Resmed Corp
Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
Guangdong Youmeng Electrical Technology Co., Ltd.
Natus Ultrapro S100 (982A0594)
Natus Neurology Incorporated
Exeter® X3® RimFit® Cup
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Mural Clinical Viewer
Ge Medical Systems Information Technologies, Inc.
Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper For
Katalyst Surgical, LLC
Elecsys Testosterone II
Roche Diagnostics
Esthetic Colorant
Kuraray Noritake Dental, Inc.
Mimics Thoracic Planner
Materialise NV
LVivo IQS
Dia Imaging Analysis, Ltd.
Y-Knotless Flex Anchors
CONMED Corporation
Accu-Chek Safe-T-Pro Uno Lancing Device
Roche Diabetes Care, Inc.
Luja Set
Coloplast Corp.
OFIX MIS App
Orthofix US, LLC
Eclipse Treatment Planning System (v18.0)
Varian Medical Systems, Inc.
Antimicrobial Silicone PHMB Foam Wound Dressing
Advanced Medical Solutions Limited
Premier's MultiMatch Universal Chameleon Restorative Composite
Premier Dental Products Company
MSFX Mikron Cervical Anterior Plate System
Mikron Makina Sanayi VE Ticaret Ltd. Sti.
Digital Routines
Gnc Holdings, LLC
Catalyst R1 Reverse Shoulder System
Catalyst Orthoscience, Inc.
Arc Adjustable Radial Cuff Compression Device
Tz Medical, Inc.
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