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calendar

19 catalysts · 14 device 510k · 5 approval

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  • device 510k14
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therapy area

no tagged catalysts yet

Week of Jan 27, 2025

19
›Jan 31, 2025approval561d ago
SOGROYA (SOMAPACITAN-BECO) — FDA approvalsomatriptan albumin bound LA

Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →somatriptan albumin bound LA →fda approvals ↗
›Jan 31, 2025approval561d agoPAXLOVID (COPACKAGED) (NIRMATRELVIR) — FDA approvalPAXLOVID (COPACKAGED)

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →PAXLOVID (COPACKAGED) →fda approvals ↗
›Jan 31, 2025approval561d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: MACLEODS PHARMS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗
›Jan 31, 2025approval561d agoUNASYN (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗
›Jan 31, 2025approval561d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

full page →fda approvals ↗
›Jan 31, 2025device 510k561d agoAvanos Medical, Inc. — Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La (510k cleared)AVANOS MEDICAL, INC.

Product code: IRP. Advisory committee: Physical Medicine. Type: Special

full page →fda device 510k ↗
›Jan 31, 2025device 510k561d agoZheJiang Decans Medical Devices Co., Ltd. — Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) (510k cleared)

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

full page →fda device 510k ↗
›Jan 31, 2025device 510k561d agoMarzzan Lucas Jorge — AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) (510k cleared)

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

full page →fda device 510k ↗
›Jan 31, 2025device 510k561d agoLuxottica Group S.P.A. — Nuance Audio Hearing Aid Software (510k cleared)

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

full page →fda device 510k ↗
›Jan 31, 2025device 510k561d agoSuzhou Master Machinery Manufacturing Co.,Ltd — Mobility Scooter (MS160A) (510k cleared)

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

full page →fda device 510k ↗
›Jan 31, 2025device 510k561d agoNanjing Synthgene Medical Technology Co., Ltd. — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream (510k cleared)

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

full page →fda device 510k ↗
›Jan 31, 2025device 510k561d agoMotilitycount Aps — SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) (510k cleared)

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

full page →fda device 510k ↗
›Jan 31, 2025device 510k561d agoDornier Medtech America — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 (510k cleared)

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

full page →fda device 510k ↗
›Jan 31, 2025device 510k561d agoArthrex, Inc. — Arthrex DynaNite Nitinol Staples (510k cleared)

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

full page →fda device 510k ↗
›Jan 31, 2025device 510k561d agoBasic Medical Technology, Inc. — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) (510k cleared)Medical Care Technologies Inc.

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

full page →fda device 510k ↗
›Jan 31, 2025device 510k561d agoTae Young Soft Co., Ltd. — ZeTTA PACS (510k cleared)

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

full page →fda device 510k ↗
›Jan 31, 2025device 510k561d agoGentuity, LLC — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (510k cleared)

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

full page →fda device 510k ↗
›Jan 31, 2025device 510k561d agoInnovate Orthopaedics, Ltd. — Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw (510k cleared)

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

full page →fda device 510k ↗
›Jan 31, 2025device 510k561d agoC.R. Bard, Inc. — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter, (510k cleared)

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

full page →fda device 510k ↗
$NVO46.28-0.93%
$PFE26.61-0.73%
$KVUE19.20+1.16%
$MDCE0.00020.00%
$PFE26.61-0.73%
$AVNS