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
ONVOY Acetabular System
Globus Medical, Inc.
Mobility Scooter (S3)
Shenzhen Zhimahuaerkai Technology Co., Ltd.
Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
Unimed Medical Supplies, Inc.
Swang-Ganz IQ pulmonary artery catheter
Edwards Lifesiences, LLC
Planmed Clarity 2D, Planmed Clarify S
Planmed OY
SACS PRO
Elastimed , Ltd.
b-ONE MOBIO Total Knee System
B-One Ortho, Corp.
CoAptix S System
University of Utah, Department of Orthopaedics
Disposable, vinyl examination gloves, Yellow
Dezhou Hengchang Medical Technology Co., Ltd.
4CIS Chiron Spinal Fixation System
Solco Biomedical Co., Ltd.
EMERGE Anterior Cervical Plate System
Evolution Spine
Zimmer Persona Personalized Knee System
Zimmer, Inc.
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Centers for Disease Control and Prevention
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
Stryker Corporation
BioXmark
Nanovi A/S
QFR (3.0)
Qfr Solutions BV
Arthrex SoftStitch
Arthrex, Inc.
Powder-Free Nitrile Examination Gloves
Global Protection Corp.
Durex Penck III Regular
Rb Health (Us), LLC
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fe
Central Medicare Sdn Bhd
VERIQA RT EPID 3D
Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla
Human Lubricant
Jiangxi Wulinxiang Biological Technology Co., Ltd.
Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)
Covidien
HAtetracell-C Titanium Cervical IBF System
Innovasis, Inc.
HealthCCSng
Zebra Medical Vision, Ltd.
Geistlich Wound Matrix PLUS
Geistlich Pharma AG
Extremity All Suture System
Field Orthopaedics
Hexa-Temp
Spident Co., Ltd.
Geonic Nasal Aspirator, Geonic Nasal Cleaner
Geon Corporation
CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)
Okapi Medical, LLC Dba Resivant Medical
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