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calendar

22 catalysts · 21 device 510k · 1 approval

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no tagged catalysts yet

Week of Mar 10, 2025

22
›Mar 14, 2025approval535d ago
BUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: MICRO LABS. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
›Mar 14, 2025device 510k535d agoOrthoPediatrics Corp. — VerteGlide Spinal Growth Guidance System (510k cleared)ORTHOPEDIATRICS CORP

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

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoAion Biosystems, Inc. — AION TempShield™ (510k cleared)NED Biosystems Inc

Product code: FLL. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoShenzhen Sanping Image Technology Co., Ltd. — Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1) (510k cleared)

Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoDosisoft SA — PLANET Onco Dose (3.2) (510k cleared)

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

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoCenters for Disease Control and Prevention — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) (510k cleared)Hubei Provincial Center for Disease Control and Prevention

Product code: OZE. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoNexxt Spine — NEXXT MATRIXX® SI System (510k cleared)

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

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoArrow International, LLC (A subsidiary of Teleflex, Inc.) — Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) (510k cleared)Arrow International LLC

Product code: FOZ. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoAidite (Qinhuangdao) Technology Co., Ltd. — Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) (510k cleared)

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

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoKettenbach GmbH & Co. KG — Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) (510k cleared)

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

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoKorot Co., Ltd. — KOROT Blood Pressure Monitor (KOROT P3 Accurate) (510k cleared)Kowa Co Ltd

Product code: DXN. Advisory committee: Cardiovascular. Type: Special

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoLumea, Inc. — Viewer+ (510k cleared)

Product code: QKQ. Advisory committee: Pathology. Type: Traditional

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoBaxter Healthcare Corporation — Solution Administration Sets (510k cleared)Baxter Healthcare Corp

Product code: FPA. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoArthrex, Inc. — Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor (510k cleared)

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

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoNeurologica Corporation, A Subsidiary of Samsung — BodyTom 64 (510k cleared)

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

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoMediclus Co., Ltd. — One-Fil Putty (510k cleared)

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

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoNox Medical Ehf — DeepRESP (510k cleared)

Product code: OLZ. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoPromisemed Hangzhou Meditech Co., Ltd. — Promisemed Safety Huber Needles (510k cleared)

Product code: PTI. Advisory committee: General Hospital. Type: Special

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agobioMerieux, Inc. — VITEK COMPACT PRO (510k cleared)BIOMERICA INC

Product code: LON. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoMonogram Orthopaedics, Inc. — mBôs (Monogram mBôs TKA System) (510k cleared)

Product code: OLO. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoMoon Surgical — Maestro System (REF100) (510k cleared)

Product code: QZB. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗
›Mar 14, 2025device 510k535d agoPenumbra, Inc. — Ruby XL System (510k cleared)Penumbra Inc

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

full page →fda device 510k ↗
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