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calendar

18 catalysts · 17 device 510k · 1 approval

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no tagged catalysts yet

Week of Nov 4, 2024

18
›Nov 8, 2024approval645d ago
OMEPRAZOLE — FDA approvalomeprazole DR

Sponsor: DEXCEL PHARMA. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →omeprazole DR →fda approvals ↗
›Nov 8, 2024device 510k645d agoIcad, Inc. — ProFound Detection (V4.0) (510k cleared)

Product code: QDQ. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Nov 8, 2024device 510k645d agoiSMART Developments, Ltd. — décoLITE LED Device (510k cleared)

Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗
›Nov 8, 2024device 510k645d agoGeistlich Pharma AG — Device 300397 Putty (510k cleared)

Product code: MQV. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Nov 8, 2024device 510k645d agoHermes Medical Solutions AB — Hybrid Viewer (00859873006189) (510k cleared)

Product code: KPS. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Nov 8, 2024device 510k645d agoFourth Frontier Technologies Pvt, Ltd. — Frontier X Plus (510k cleared)

Product code: MLO. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗
›Nov 8, 2024device 510k645d agoNvision Biomedical Technologies — Trigon PEEK HA Wedges (510k cleared)

Product code: PLF. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗
›Nov 8, 2024device 510k645d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System (510k cleared)

Product code: IYN. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Nov 8, 2024device 510k645d agoHironic Co., Ltd. — Plasonic (Plasonic) (510k cleared)

Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗
›Nov 8, 2024device 510k645d agoJeil Medical Corporation — Xpine Spinal Fixation System (510k cleared)

Product code: NKB. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Nov 8, 2024device 510k645d agoShenzhen Nuon Medical Equipment Co., Ltd. — Hair Growth Comb (SZ-23,SZ-23A) (510k cleared)

Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional

full page →fda device 510k ↗
›Nov 8, 2024device 510k645d agoSonoma Pharmaceuticals, Inc. — Microdacyn Hydrogel (510k cleared)Sonoma Pharmaceuticals, Inc.

Product code: FRO. Advisory committee: Unknown. Type: Traditional

full page →fda device 510k ↗
›Nov 8, 2024device 510k645d agoPulnovo Medical (Wuxi) Co., Ltd. — Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) (510k cleared)

Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗
›Nov 8, 2024device 510k645d agoHangzhou Clongene Biotech Co., Ltd. — CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette (510k cleared)Hangzhou DAC Biotech Co Ltd

Product code: NGL. Advisory committee: Clinical Toxicology. Type: Traditional

full page →fda device 510k ↗
›Nov 8, 2024device 510k645d agoGuangzhou Aimira Innovation Technology Co, Ltd. — Superflow Prime Treatment System (ASP-1M) (510k cleared)Hang Feng Technology Innovation Co., Ltd.

Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗
›Nov 8, 2024device 510k645d agoWaldemar Link GmbH & Co. KG — MobileLink Acetabular Cup System - Line Extension (Multiple) (510k cleared)

Product code: LPH. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Nov 8, 2024device 510k645d agoRizhao Huge Biomaterials Company, Ltd. — TopCEM Ceramic Primer Ceramic Coupling Agent (510k cleared)

Product code: KLE. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗
›Nov 8, 2024device 510k645d agoSTERIS Corporation — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) (510k cleared)STERIS plc

Product code: ODC. Advisory committee: Gastroenterology, Urology. Type: Special

full page →fda device 510k ↗
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