Calendar

pharmadog

Week of Oct 13, 2025

Oct 17, 2025device pma302d agoMedtronic Neuromodulation — Altaviva Implantable Neurostimulator (PMA supplement)

Supplement type: 30-Day Notice. Product code: QPT. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗

Oct 17, 2025device pma302d agoAbbott Molecular, Inc. — Alinity m HR HPV (PMA supplement)

Supplement type: Real-Time Process. Product code: MAQ. Advisory committee: MI. Decision: APPR

full page →fda device pma ↗

Oct 17, 2025device pma302d agoSiemens Healthcare Diagnostics — Atellica IM Hepatitis B core IgM (aHBcM) (PMA supplement)

Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

full page →fda device pma ↗

Oct 17, 2025device pma302d agoAbbott Vascular, Inc. — XACT Carotid Stent System (XACT CSS) and XACT Transcarotid Stent System (XACT TSS) (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Oct 17, 2025device pma302d agoSiemens Healthcare Diagnostics — Atellica IM Hepatitis B e Antigen (HBeAg) (PMA supplement)

Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

full page →fda device pma ↗

Oct 17, 2025device pma302d agoSiemens Corp. — Atellica IM Hepatitis B surface Antigen II (HBsII) & Atellica IM Hepatitis B surface Antigen II Confirmatory (PMA supplement)

Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

full page →fda device pma ↗

Oct 17, 2025device pma302d agoBoston Scientific — RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (M004RA65010); Rhythmia HDx Ablation Connection Box (Maestro) (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: OAD. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Oct 17, 2025device pma302d agoSiemens Healthcare Diagnostics, Inc. — Atellica IM HBc Total 2 (HBcT2) (PMA supplement)

Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

full page →fda device pma ↗

Oct 17, 2025device pma302d agoBoston Scientific Corp — RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (M004RA65010); Rhythmia HDx Ablation Connection Box (Maestro) (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: OAD. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Oct 17, 2025device pma302d agoSiemens Corp. — Atellica IM Hepatitis B surface Antigen II (HBsII) (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: LOM. Advisory committee: MI. Decision: APPR

full page →fda device pma ↗

Oct 17, 2025device pma302d agoSiemens Healthcare Diagnostics, Inc. — Atellica IM Anti-HBe2 (aHBe2) (PMA supplement)

Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

full page →fda device pma ↗

Oct 17, 2025device pma302d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System, HeartMate II Left Ventricular Assist System (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Oct 17, 2025device pma302d agoBeckman Coulter, Inc. — Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (PMA)

Product code: LOM. Advisory committee: MI. Decision: APRL

full page →fda device pma ↗

Oct 17, 2025device pma302d agoAbbott Molecular, Inc. — Alinity m HBV (PMA supplement)

Supplement type: Real-Time Process. Product code: MKT. Advisory committee: MI. Decision: APPR

full page →fda device pma ↗

Oct 17, 2025device pma302d agoABBOTT MEDICAL — HeartMate Apical Coring Knife (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Oct 17, 2025device pma302d agoSiemens Healthcare Diagnostics, Inc. — Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) (PMA supplement)

Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR

full page →fda device pma ↗

Oct 17, 2025device pma302d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® Endoprosthesis; GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Oct 17, 2025device pma302d agoBoston Scientific Corp — RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (M004RA65010) (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: LPB. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Oct 17, 2025device recall302d agoTECHNO-PATH MANUFACTURING LTD. device recall (Cls II)PATH

Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG. — Reason: Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform. — Status: Ongoing

full page →fda device recalls ↗

Oct 17, 2025device recall302d agoMozarc Medical US LLC device recall (Cls II)

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing

full page →fda device recalls ↗

Oct 17, 2025device recall302d agoCareFusion 303, Inc. device recall (Cls I)

BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide — Reason: If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated. — Status: Ongoing

full page →fda device recalls ↗

Oct 17, 2025device recall302d agoMozarc Medical US LLC device recall (Cls II)

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing

full page →fda device recalls ↗

Oct 17, 2025device recall302d agoStraumann USA LLC device recall (Cls II)

Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10; — Reason: The possibility for this product that is intended for demonstration purposes only to be placed in patients. — Status: Ongoing

full page →fda device recalls ↗

Oct 17, 2025device recall302d agoOlympus Corporation of the Americas device recall (Cls II)

Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned on the catheter inside the balloon that define the working length — Reason: Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit. — Status: Ongoing

full page →fda device recalls ↗

Oct 17, 2025device recall302d agoTECHNO-PATH MANUFACTURING LTD. device recall (Cls II)PATH

Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG. — Reason: Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform. — Status: Ongoing

full page →fda device recalls ↗

Oct 17, 2025device recall302d agoMozarc Medical US LLC device recall (Cls II)

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing

full page →fda device recalls ↗

Oct 17, 2025device recall302d agoMozarc Medical US LLC device recall (Cls II)

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing

full page →fda device recalls ↗

Oct 17, 2025device recall302d agoMozarc Medical US LLC device recall (Cls II)

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing

full page →fda device recalls ↗

Oct 17, 2025device recall302d agoMozarc Medical US LLC device recall (Cls II)

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing

full page →fda device recalls ↗

Oct 17, 2025device recall302d agoINTELERAD MEDICAL SYSTEMS INCORPORATED device recall (Cls II)

IntelePACS - InteleConnect / TechPortal — Reason: Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making. — Status: Ongoing

full page →fda device recalls ↗

Oct 18, 2025device recall301d agoAuris Health, Inc device recall (Cls II)

MONARCH Bronchoscope. Model Number: MBR-000211-B — Reason: Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks. — Status: Ongoing

full page →fda device recalls ↗

Week of Oct 20, 2025

Oct 20, 2025approval299d agoBEYFORTUS (NIRSEVIMAB-ALIP) — FDA approvalnirsevimab

Sponsor: ASTRAZENECA AB. Form: INJECTABLE. Route: INJECTION

full page →nirsevimab →fda approvals ↗

Oct 20, 2025approval

← prev

page 9 of 283

Week of Oct 13, 2025

Week of Oct 20, 2025