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calendar

19 catalysts · 15 device 510k · 4 approval

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no tagged catalysts yet

Week of Jan 13, 2025

19
›Jan 16, 2025approval576d ago
CARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →carbamazepine ER →fda approvals ↗
›Jan 16, 2025approval576d agoARTESUNATE — FDA approvalARTESUNATE

Sponsor: AMIVAS. Form: POWDER. Route: INTRAVENOUS

full page →ARTESUNATE →fda approvals ↗
›Jan 16, 2025approval576d agoCALQUENCE (ACALABRUTINIB MALEATE) — FDA approvalCALQUENCE

Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL

full page →CALQUENCE →fda approvals ↗
›Jan 16, 2025approval576d agoCALQUENCE (ACALABRUTINIB) — FDA approvalCALQUENCE

Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

full page →CALQUENCE →fda approvals ↗
›Jan 16, 2025device 510k576d agoInmedix, Inc. — CloudHRV™ System (100-01-001) (510k cleared)

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

full page →fda device 510k ↗
›Jan 16, 2025device 510k576d agoYa-Man, Ltd. — Medi Lift Mask (510k cleared)

Product code: NFO. Advisory committee: Neurology. Type: Special

full page →fda device 510k ↗
›Jan 16, 2025device 510k576d agoCala Health, Inc. — Cala kIQ (510k cleared)CARDINAL HEALTH INC

Product code: QBC. Advisory committee: Neurology. Type: Special

full page →fda device 510k ↗
›Jan 16, 2025device 510k576d agoWondfo USA Co, Ltd. — WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest (510k cleared)

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

full page →fda device 510k ↗
›Jan 16, 2025device 510k576d agoVieworks Co., Ltd. — VIVIX-M (510k cleared)

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

full page →fda device 510k ↗
›Jan 16, 2025device 510k576d agoDeka Research and Development Corp. — Remunity 2.0 Pump for Remodulin (treprostinil) Injection (510k cleared)UNITED THERAPEUTICS Corp

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

full page →fda device 510k ↗
›Jan 16, 2025device 510k576d agoPearl, Inc. — Second Opinion CC (510k cleared)

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

full page →fda device 510k ↗
›Jan 16, 2025device 510k576d agoStryker Instruments — System 9 Sterile Battery Container (510k cleared)

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

full page →fda device 510k ↗
›Jan 16, 2025device 510k576d agoNu Eyne Co., Ltd. — ADDNOX (BPSPM1) (510k cleared)

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

full page →fda device 510k ↗
›Jan 16, 2025device 510k576d agoBiofire Diagnostics, LLC — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid (510k cleared)

Product code: PCH. Advisory committee: Microbiology. Type: Special

full page →fda device 510k ↗
›Jan 16, 2025device 510k576d agoAxis-Shield Diagnostics, Ltd. — Alere NT-proBNP for Alinity i Reagent Kit (510k cleared)

Product code: NBC. Advisory committee: Clinical Chemistry. Type: Traditional

full page →fda device 510k ↗
›Jan 16, 2025device 510k576d agoRoche Molecular Systems, Inc. — cobas® liat CT/NG/MG nucleic acid test (510k cleared)

Product code: QEP. Advisory committee: Microbiology. Type: Dual Track

full page →fda device 510k ↗
›Jan 16, 2025device 510k576d agoPepper Interactive, Inc. — Pepper EMS Training System (510k cleared)PELOTON INTERACTIVE, INC.

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

full page →fda device 510k ↗
›Jan 16, 2025device 510k576d agoPearl Digital, Inc. — Pearl Clear Aligner (510k cleared)

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

full page →fda device 510k ↗
›Jan 16, 2025device 510k576d agoHunan Vathin Medical Instrument Co., Ltd. — Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL (510k cleared)

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

full page →fda device 510k ↗
$UTHR499.73-0.31%
$PTON
$AZN156.45-0.50%
$CAH235.17+1.70%
$AZN156.45-0.50%