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calendar

13 catalysts · 11 device 510k · 2 approval

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no tagged catalysts yet

Week of Feb 10, 2025

13
›Feb 13, 2025approval564d ago
TRUQAP (CAPIVASERTIB) — FDA approvalcapivasertib

Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL

full page →capivasertib →fda approvals ↗
›Feb 13, 2025approval564d agoDENOSUMAB-DSSB — FDA approvaldenosumab biosimilar

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →denosumab biosimilar →fda approvals ↗
›Feb 13, 2025device 510k564d agoMaxx Orthopedics, Inc. — Freedom® Total Knee System - Porous Tibial Base Plate (510k cleared)

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

full page →fda device 510k ↗
›Feb 13, 2025device 510k564d agoAssure Tech., LLC — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette (510k cleared)

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

full page →fda device 510k ↗
›Feb 13, 2025device 510k564d agoNewclip Technics — Newclip Patient-matched instrumentation non sterile PSI (510k cleared)

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

full page →fda device 510k ↗
›Feb 13, 2025device 510k564d agoDentsply Sirona, Inc. — AH Plus Endodontic Sealer (510k cleared)DENTSPLY SIRONA Inc.

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

full page →fda device 510k ↗
›Feb 13, 2025device 510k564d agoPenumbra, Inc. — Penumbra System (Reperfusion Catheter RED 72) (510k cleared)Penumbra Inc

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

full page →fda device 510k ↗
›Feb 13, 2025device 510k564d agoHologic, Inc. — Aptima SARS-CoV-2 Assay (510k cleared)

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

full page →fda device 510k ↗
›Feb 13, 2025device 510k564d agoBoston Aesthetics, Inc. — Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) (510k cleared)

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

full page →fda device 510k ↗
›Feb 13, 2025device 510k564d agoJmt Co., Ltd. — EDEN ControlCath (510k cleared)

Product code: BSO. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗
›Feb 13, 2025device 510k564d agoNeuromodulatory Devices & Applications — Ampa One System (AMPA-001) (510k cleared)

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

full page →fda device 510k ↗
›Feb 13, 2025device 510k564d agoDenjoy Dental Co., Ltd. — Integrated Endo System (Meet Endo-II) (510k cleared)

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

full page →fda device 510k ↗
›Feb 13, 2025device 510k564d agoFitbit, LLC — Body Temperature Software (BTS) (510k cleared)

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

full page →fda device 510k ↗
$AZN162.70-1.11%
$XRAY11.12+0.72%
$PEN324.29-0.11%