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calendar

13 catalysts · 12 device 510k · 1 approval

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no tagged catalysts yet

Week of Nov 11, 2024

13
›Nov 12, 2024approval658d ago
VONJO (PACRITINIB CITRATE) — FDA approvalpacritinib

Sponsor: SOBI. Form: CAPSULE. Route: ORAL

full page →pacritinib →fda approvals ↗
›Nov 12, 2024device 510k658d agoPhenox, Ltd. — pNOVUS 21 Microcatheter (510k cleared)

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

full page →fda device 510k ↗
›Nov 12, 2024device 510k658d agoFoshan Soco Precision Instrument Co., Ltd. — High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) (510k cleared)

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

full page →fda device 510k ↗
›Nov 12, 2024device 510k658d agoSteris — VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator (510k cleared)STERIS plc

Product code: SDC. Advisory committee: General Hospital. Type: Direct

full page →fda device 510k ↗
›Nov 12, 2024device 510k658d agoPrognosys Medical Systems Private Limited — PRORAD X-Ray Flat Panel Detector with DROC (510k cleared)

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

full page →fda device 510k ↗
›Nov 12, 2024device 510k658d agoChange Healthcare Canada Company — Change Healthcare Stratus Imaging PACS (510k cleared)

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

full page →fda device 510k ↗
›Nov 12, 2024device 510k658d agoVyaire Medical, Inc. — AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask (510k cleared)VYCOR MEDICAL INC

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

full page →fda device 510k ↗
›Nov 12, 2024device 510k658d agoMedtronic Minimed — InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (510k cleared)

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

full page →fda device 510k ↗
›Nov 12, 2024device 510k658d agoSoul Mobility — Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) (510k cleared)

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

full page →fda device 510k ↗
›Nov 12, 2024device 510k658d agoLifesignals, Inc. — UbiqVue™ 2A Multi-parameter System (UX2550) (510k cleared)

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

full page →fda device 510k ↗
›Nov 12, 2024device 510k658d agoZhejiang Kairui Medical Device Co., Ltd. — Electric wheelchair (KR-8807) (510k cleared)

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

full page →fda device 510k ↗
›Nov 12, 2024device 510k658d agoColoplast Corp. — Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) (510k cleared)

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

full page →fda device 510k ↗
›Nov 12, 2024device 510k658d agoSupermax Healthcare Canada – Supermax Medical — Aurelia Surgical Mask ASTM Level-3 (2130) (510k cleared)

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

full page →fda device 510k ↗
$VYCO0.06600.00%
$STE233.78+0.35%