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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