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calendar

17 catalysts · 16 device 510k · 1 approval

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no tagged catalysts yet

Week of Oct 14, 2024

17
›Oct 16, 2024approval685d ago
VYALEV (FOSCARBIDOPA) — FDA approval(foscarbidopa + foslevodopa)

Sponsor: ABBVIE. Form: SOLUTION. Route: SUBCUTANEOUS

full page →(foscarbidopa + foslevodopa) →fda approvals ↗
›Oct 16, 2024device 510k685d agoStryker Instruments — Stryker Steri-Shield 8 Surgical Hoods and Togas (510k cleared)

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

full page →fda device 510k ↗
›Oct 16, 2024device 510k685d agoAugmedics, Ltd. — xvision Spine System (510k cleared)

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

full page →fda device 510k ↗
›Oct 16, 2024device 510k685d agoAbbott Laboratories Diagnostics Division — Alkaline Phosphatase (510k cleared)ABBOTT LABORATORIES

Product code: CJE. Advisory committee: Clinical Chemistry. Type: Special

full page →fda device 510k ↗
›Oct 16, 2024device 510k685d agoCerenovus, Inc. — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set (510k cleared)

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

full page →fda device 510k ↗
›Oct 16, 2024device 510k685d agoLi Medical Corporation , Ltd. — RELIEEV Uterine Manipulator Injector (CUMI 5.0) (510k cleared)

Product code: LKF. Advisory committee: Obstetrics/Gynecology. Type: Traditional

full page →fda device 510k ↗
›Oct 16, 2024device 510k685d agoCerenovus, Inc. — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter (510k cleared)

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

full page →fda device 510k ↗
›Oct 16, 2024device 510k685d agoShenzhen Safesecure Medical Infection Control Tech Co. , Ltd. — Safe Secure Sterilization Pouches and Rolls (510k cleared)

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

full page →fda device 510k ↗
›Oct 16, 2024device 510k685d agoPeytant Solutions, Inc. — AMStent® Tracheobronchial Covered Stent System (510k cleared)PDF SOLUTIONS INC

Product code: SDB. Advisory committee: Anesthesiology. Type: Direct

full page →fda device 510k ↗
›Oct 16, 2024device 510k685d agoDualams, Inc., Dba Airkor — UltraEzAir® (UEA1A) (510k cleared)

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

full page →fda device 510k ↗
›Oct 16, 2024device 510k685d agoShenzhen Hbcare Technology Co.,Ltd — Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗
›Oct 16, 2024device 510k685d agoJLK, Inc. — JLK-CTP (510k cleared)

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

full page →fda device 510k ↗
›Oct 16, 2024device 510k685d agoVy Spine, LLC — Vy Spine™ VyLam™ Laminoplasty System (510k cleared)

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

full page →fda device 510k ↗
›Oct 16, 2024device 510k685d agoEdwards Lifesciences — Cerebral Autoregulation Index (CAI) Algorithm (510k cleared)Edwards Lifesciences Corp

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

full page →fda device 510k ↗
›Oct 16, 2024device 510k685d agoVarian Medical Systems, Inc. — ONCOZENE Microspheres (510k cleared)MERIT MEDICAL SYSTEMS INC

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

full page →fda device 510k ↗
›Oct 16, 2024device 510k685d agoAmbu A/S — Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2 (510k cleared)

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

full page →fda device 510k ↗
›Oct 16, 2024device 510k685d agoKunshan Hi-Fortune Health Products Co., Ltd. — Electrically powered wheelchair (510k cleared)

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

full page →fda device 510k ↗
$ABBV255.48-1.03%
$EW91.33-2.47%
$FRTRY
$MMSI90.49+1.06%
$PDFS
$ABT112.47+0.79%