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
PiXel8-Reveal
Rohrer Aesthetics
F&P Nova Nasal Mask
Fisher & Paykel Healthcare Limited
Catapult Guide Sheath
Contract Medical International, GmbH
VI°Port Liver Preservation System
Traferox Technologies, Inc.
LOCATOR® Angled Abutment
Zest Anchors, LLC
leva Pelvic Health System
Renovia, Inc.
Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
Medline Industries, Inc.
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
Ortho Clinical Diagnostics
Access Thyroglobulin Antibody II
Beckman Coulter, Inc.
Insight Enhanced DRF (EN-1002-01)
Imaging Engineering, LLC
i2Contour
Mrimath, LLC
Luja Coude (20108 Male CH18 - large packaging)
Coloplast Corp.
Keos Anterior Cervical Interbody Fusion Device System
Keos
VPAP Pediatric Face Mask
Hsiner Co., Ltd.
Ziehm Vision RFD 3D
Ziehm Imaging GmbH
TearCare System
Sight Sciences, Inc.
LILY Extension Tube and Needleless Connector
Lily Medical Corporation
MAGNETOM Vida, MAGNETOM Sola
Siemens Medical Solutions USA, Inc.
Vis-U-All Low Temperature Sterilization Pouches
STERIS Corporation
Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)
Jiangxi Aicare Medical Technology Co., Ltd.
Anchor Bolts as Accessories to Depth Electrodes
Ad-Tech Medical Instrument Corporation
NovoSorb BTM
Polynovo Biomaterials Pty, Ltd.
Peleton Universal Single Use Power System and Attachments
Peleton Surgical
NightGuard Flex
Sprintray, Inc.
G0 Blood Pressure Monitoring System (G0)
Aktiia SA
ROSA ONE Brain application
Medtech S.A.S
ZQuiet Advance
Sleeping Well, LLC
MISHA Knee System
Moximed, Inc.
mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
MED-EL Elektromedizinische Geräte GmbH
Pocket Ultrasound System
Guangdong Youkey Medical Co., Ltd.
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