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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

ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™;

ABBOTT MEDICAL

Eko Murmur Analysis Software (EMAS)

Eko Devices, Inc.

Yomi Robotic System

Neocis, Inc.

Model 9100 PFT/DICO

Vitalograph Ireland, Ltd.

PerioStom Dental Dressing

Forward Science, LLC

DD Hybridlayer (multicolored zirconia)

Dental Direkt GmbH

IPL Hair Removal Device

Shenzhen Noble Smart Manufacturing Tech Co., Ltd.

VariLift®-C Interbody Fusion System

Wenzel Spine, Inc.

qER-Quant

Qure.Ai Technologies

Cellbrick Knee Spacer

United Orthopedic Corporation

Resonic Rapid Acoustic Pulse Device

Soliton, Inc.

IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit

Millennium Medical Technologies Inc (Dba Cellmyx)

IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL

Bestway Plastic and Metal Products , Ltd.

BPS Wrist Fracture System

Orthonovis, Inc.

Kinos Total Ankle System

Restor3D

Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print

Vigodent Indústria E Comercio Ltda

Veincare

Wontech Co., Ltd.

Deep Learning Image Reconstruction

Ge Medical Systems, LLC

SOL-CARE IV Bag Safety Connector

Sol-Millennium Medical Group

Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)

Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.

NobelProcera Zirconia N1 Base

Nobel Biocare Services AG

ATOZ Mini-Screw

Mk Meditech, Inc.

NuVasive Anterior Cervical Plate Systems

Nu Vasive, Incorporated

“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)

Braxx Biotech Co., Ltd.

Lyra RSV+hMPV Assay

Quidel Corporation

Overjet Iris Intelligent Imaging System

Overjet, Inc.

Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR

Olympus Medical Systems Corp.

Medical surgical mask

Guangdong Kingfa Sci. & Tech.Co., Ltd.

MuscleView 2.0

Springbok, Inc. (Dba Springbok Analytics)

c1Trac

Zimmer Medizinsysteme GmbH

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