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Welspun India Receives U.S. FDA 510(k) Clearance for its 3 Ply Surgical Masks

2021-09-30 15:51:16| Nonwovens Industry Breaking News

Masks are made with 100% polypropylene and offer 98% protection against bacterial load

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Olympus Receives 510(k) Clearance for TJF-Q180V Duodenoscope

2016-01-21 11:31:09| Industrial Newsroom - All News for Today

CENTER VALLEY, Pa.  Olympus announced today that FDA has cleared the 510(k) for the TJF-Q180V duodenoscope with modifications to the device design and labeling. The duodenoscope is a flexible gastrointestinal endoscope used in procedures such as endoscopic retrograde cholangiopancreatography (ERCP), which is most...

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Qfix Receives 510(k) Clearance for Encompass(TM) SRS Immobilization System

2015-12-10 11:31:11| Industrial Newsroom - All News for Today

AVONDALE, Pa. - Today, Qfix (www.Qfix.com), a world leader in radiotherapy patient positioning devices, announced the Encompass SRS Immobilization System has received 510(k) clearance from the US FDA for stereotactic radiosurgery (SRS). The Encompass has been used for intracranial radiotherapy treatments for nearly...

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PCI Medical Announces FDA 510(k) Clearance for ASTRA VR and ASTRA TEE Automated Reprocessors for Endovaginal/Endorectal Probes and TEE Ultrasound Probes

2015-11-25 11:31:10| Industrial Newsroom - All News for Today

Deep River, Connecticut PCI Medical is pleased to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration for the ASTRA VR and ASTRA TEE automated reprocessors used to facilitate the high-level disinfection of endocavity ultrasound probes. "The ASTRA VR and ASTRA TEE automated...

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Philips Receives FDA 510(k) Clearance for Spectral Diagnostic Suite

2015-09-14 12:31:15| Industrial Newsroom - All News for Today

On-demand visualization and analytics solution for Philips IQon Spectral CT delivers expanded clinical applications and drives diagnostic confidence ANDOVER, Mass. - Reinforcing its commitment to improving diagnostic confidence through innovation, Royal Philips (NYSE: PHG AEX: PHIA) today announced that it has...

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