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Home » Topics » Medical Devices » Submissions and Approvals

Submissions and Approvals
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Invictus Aura Storm Air Purifier Gets 510(k) Clearance

June 30, 2022
The FDA has granted 510(k) marketing clearance to Invictus Sterilization’s Aura Storm hospital-grade ultraviolet medical air purifier. The North Carolina-based company makes surface and air sterilization products that use ultraviolet C light. Read More

Saneso’s 360-Degree Colonoscope Receives FDA Clearance

June 30, 2022
Endoscopists discovered more polyps with Saneso’s device versus traditional single-camera colonoscopes. Read More

AeroClean Granted FDA Clearance for Its Pūrgo Medical-Grade Air Hygiene Tech

June 30, 2022
The device delivers hospital-grade HEPA filtration and germicidal ultraviolet irradiation. Read More

Zavation’s eZspand Lateral Cage Cleared

June 30, 2022
The cage adjusts up to a 15-degree lordosis angle to allow for the inward curve of the lumbar spine. Read More

CardieX Submits First Dual Blood Pressure and Arterial Health Monitor for FDA Clearance

June 29, 2022
Australia-based CardieX and its manufacturing partner Andon have filed a 510(k) premarket submission with the FDA for the CONNEQT Pulse, the world’s first dual blood pressure and arterial health monitor. Read More

Spindiag Gains CE-IVD Marks for Two Rapid PCR Tests

June 29, 2022
Spindiag also received a CE-IVD certification for its test for methicillin-resistant Staphylococcus aureus (MRSA), which causes hard-to-treat infections in humans. Read More

DxLab Gets FDA’s Emergency Use Authorization for Its COVID-19 Test

June 29, 2022
The test can be used for qualitative detection of nucleic acid from the SARS-CoV-2 coronavirus from nasal swab samples from individuals suspected by their healthcare provider of being infected with COVID-19. Read More

Okami Medical’s LOBO-7 and LOBO-9 Vascular Occluders Cleared

June 29, 2022
The occluders have a highly occlusive braided structure that rapidly reduces flow. Read More

Embody’s Rotator Cuff Repair System Cleared

June 28, 2022
Embody has received the FDA’s 510(k) marketing clearance for its Tapestry RC system for rotator cuff repair. Read More

J&J Vision’s Acuvue Oasys Contact Lenses Cleared

June 28, 2022
The company plans to launch the new lenses in the U.S. and Canada in the autumn. Read More

PH&S Products Awarded FDA Clearance for Fentanyl and Heroin Resistant Gloves

June 28, 2022
Testing showed that fentanyl, heroin and gastric acid did not permeate the gloves during up to 240 minutes of exposure. Read More

Aurora Spine Gets FDA Clearance for Spinal Fusion Device

June 28, 2022
The stand-alone device is intended for lumbar interbody fusion procedures. Read More
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