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VariTrax Sternal CircumFixation System
Device Information Indications The VariTrax Sternal CircumFixation System is indicated for the primary or secondary closure or repair of the sternum following sternotomy or fracture. It stabilizes the sternum and promotes fusion. Intended Use The device is intended for individuals requiring sternal closure after sternotomy or sternal fracture. It stabilizes the sternum and aids in…
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Redemption Duo Hindfoot Nail System
Device Information Indications The Redemption Duo Hindfoot Nail System is intended for tibiotalocalcaneal arthrodesis (fusion) and is used in patients with previously infected arthrosis, revision ankle arthrodesis, failed total ankle arthroplasty, avascular necrosis of the talus, severe deformity or instability (as a result of talipes equivarus, cerebral vascular accident, paralysis or other neuromuscular disease), rheumatoid…
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MightySat – OTC
Device Information Indications The Masimo MightySat-OTC is intended for spot-checking functional oxygen saturation (SpO2) of arterial hemoglobin and pulse rate (PR). Intended Use (Including Who Can Use This Device) The device is intended for use by individuals 18 years or older, either healthy or poorly perfused. Availability The device is available over-the-counter (OTC). Contraindications The…
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CardioCurve Steerable Sheath
Device Information Indications The CardioCurve Steerable Sheath is indicated for introducing cardiovascular devices to the epicardial or endocardial surfaces of the heart, including the left side, through the interatrial septum. Intended Use The device is used for minimally invasive procedures to access the heart’s surfaces for cardiovascular devices. Availability Prescription use only (21 CFR 801…
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Clearblue Early Detection Pregnancy Test
Device Information Indications The Clearblue Early Detection Pregnancy Test is intended for over-the-counter use to detect hCG levels in urine as an early indicator of pregnancy. It can be used as early as six days before the missed period or five days before the expected period. Intended Use This test is intended for home use…
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Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
Device Information Indications The Microwave Ablation Device Exceed S10U is indicated for soft tissue coagulation (ablation) during procedures by healthcare professionals in healthcare facilities. It is not intended for cardiac use. Sterile Microwave Ablation Probe is used with Microwave Ablation Device. Intended Use of Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) The…
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Genius Digital Diagnostics System with the Genius Cervical AI Algorithm
Device Information Indications The Genius Digital Diagnostics System with the Genius Cervical AI Algorithm is designed for creating and viewing digital images of scanned ThinPrep Pap Test slides. The system aids in cervical cancer screening by identifying atypical cells, cervical neoplasia, including precursor lesions (High and Low-grade Squamous Intraepithelial Lesions), and carcinoma. Limitations The system…
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Digital Thermometer Model T28 T28L
Device Information Indications The Digital Thermometer Model T28 T28L measures and monitors human body temperature through oral or axillary sites. It is suitable for people of all ages and can be used by doctors or users in hospitals or at home. Intended Use It is intended for use in both hospital and home settings. The…
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CEPHX – Cephalometric Analysis Software
Device Information Indications CEPHX – Cephalometric Analysis Software is designed for dentists providing orthodontic treatment. It assists in image analysis, simulation, profilogram, VTO (Visual Treatment Objective), and patient consultation. The software is intended for use on patients 14 years and older. Results depend on interpretation by trained and licensed practitioners. Intended Use The software is…
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Ziehm Solo FD
Device Information Indications The Ziehm Solo FD is intended to provide medical imaging for adults and pediatric populations. It uses pulsed and continuous fluoroscopic imaging to capture and display images for diagnostic, interventional, and surgical procedures. Clinical applications include, but are not limited to, pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical…
Medevx
Medical Device Information Database
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