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9,257 catalysts · 3,086 8k filing · 2,032 grant · 1,000 device adverse event · 910 approval · 674 device 510k · 583 earnings
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9,257 catalysts · 3,086 8k filing · 2,032 grant · 1,000 device adverse event · 910 approval · 674 device 510k · 583 earnings
Sponsor: GILEAD SCIENCES INC. Form: CAPSULE. Route: ORAL
Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: EPIC PHARMA LLC. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: CHEPLAPHARM. Form: POWDER. Route: INTRAMUSCULAR
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: ALKERMES INC. Form: TABLET. Route: ORAL
Sponsor: PLATINUM. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL
Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS
Sponsor: NOVO. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: IMMUNEX. Form: SYRINGE
Sponsor: JUBILANT GENERICS. Form: TABLET. Route: ORAL
Product code: GQG. Advisory committee: Microbiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: EBW. Advisory committee: Dental. Type: Traditional
Product code: FDF. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KDN. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: POK. Advisory committee: Radiology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DWF. Advisory committee: Cardiovascular. Type: Traditional
Product code: SCL. Advisory committee: General Hospital. Type: Traditional
Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: NIU. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30
Product code: SGU. Advisory committee: NE. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: PRC. Advisory committee: CV. Decision: APPR
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 — Reason: A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment — Status: Ongoing
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851 — Reason: The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older. — Status: Ongoing
DxC 700 AU, REF: B86444, B86446 — Reason: A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment. — Status: Ongoing
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 2100491-006, 2088026-723, 2088026-308, 2104867-044, 2100491-012, 2088026-962, 2088026-969, 2102676-001, 2088026-936, 2088026-960, K1220JWED, 2088026-806, 2088026-506, 2088026-026, 2088026-970, 2088026-943, 2088026-990, 2088026-940, 2088026-959, 2088026-967, 2088026-989, 2104867-045, 2088026-993, 2088026-306, 2102675-010, 2088026-948, 2088026-957, 2088026-973, 2088026-946, 2088026-715, 2088026-906 — Reason: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data. — Status: Ongoing
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61 — Reason: Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery). — Status: Ongoing
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). — Reason: The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event. — Status: Ongoing
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150 — Reason: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data. — Status: Ongoing
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS). — Reason: Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system. — Status: Ongoing
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-032, 5826659-033, 5826659-028, 5826659-034, 5826659-030, 5826659-019, 5826659-022, 5826659-026, 5826659-023, 5826659-031, 5826659-025, 5826659-002, 5826659-021, 5826659-037, 5826659-014, 5826659-016, 5826659-013 — Reason: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data. — Status: Ongoing
EB grant. $7,140. PI: Stacy Marla Copp
AG grant. $46,086. PI: Anna Saylor
NR grant. $1,422,387. PI: EILEEN T LAKE
Product code: DQX. Advisory committee: Cardiovascular. Type: Special