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8,795 catalysts · 3,085 8k filing · 1,751 grant · 1,000 device adverse event · 820 approval · 632 device 510k · 583 earnings
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8,795 catalysts · 3,085 8k filing · 1,751 grant · 1,000 device adverse event · 820 approval · 632 device 510k · 583 earnings
NS grant. $21,100. PI: TERRY L. SHEPPARD
AI grant. $421,223. PI: ELIZABETH Ann LEADBETTER
AI grant. $916,436. PI: RUDOLF JAENISCH
AI grant. $322,096. PI: Douglas E. Brackney
AI grant. $412,942. PI: JAMES Edward BINA
AI grant. $909,998. PI: Matthew Ryan Gardner
OD grant. $487,500. PI: Na Sun
Sponsor: BARR LABS. Form: CAPSULE. Route: ORAL
Sponsor: EPIC PHARMA LLC. Form: CAPSULE. Route: ORAL
Sponsor: PH HEALTH. Form: TABLET. Route: ORAL
Sponsor: PFIZER. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: SENORES PHARMS. Form: TABLET. Route: ORAL
Sponsor: MANKIND PHARMA. Form: TABLET. Route: ORAL
Sponsor: BAXTER HLTHCARE CORP. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL
Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL
Product code: GKZ. Advisory committee: Hematology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: HQF. Advisory committee: Ophthalmic. Type: Traditional
Product code: IYO. Advisory committee: Radiology. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: JLW. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: QDQ. Advisory committee: Radiology. Type: Traditional
Product code: MHX. Advisory committee: Cardiovascular. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DQD. Advisory committee: Cardiovascular. Type: Traditional
Product code: KCT. Advisory committee: General Hospital. Type: Traditional
Product code: GAM. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MSV. Advisory committee: Immunology. Type: Traditional
Product code: SHA. Advisory committee: General, Plastic Surgery. Type: Direct
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Supplement type: Normal 180 Day Track No User Fee. Product code: LWR. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: LWR. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: QPT. Advisory committee: GU. Decision: OK30
Supplement type: Real-Time Process. Product code: OZD. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: LPC. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: MNQ. Advisory committee: AN. Decision: APPR
Supplement type: Real-Time Process. Product code: PYX. Advisory committee: CV. Decision: APPR
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE METRIX PRO Meter Only/RE4099P-40, Henry Schein TRUE METRIX PRO Kit/RE4099P-43, McKESSON TRUE METRIX PRO Meter Only/RE4051P-00, Moore Medical TRUE METRIX PRO Meter Only/RE4068P-01. — Reason: The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose. — Status: Ongoing
Artelon FlexBand Dynamic Matrix Ref: 31057 — Reason: Augmentation devices failed bacterial endotoxin testing. — Status: Ongoing
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX AIR Kit/REA4001-01, Leader TRUE METRIX AIR Kit/REA4002-01, CVS TRUE METRIX AIR Kit/REA4007-01, GNP TRUE METRIX AIR Kit/REA4011-01, Meijer TRUE METRIX AIR Kit/REA4019-01, Publix TRUE METRIX AIR Kit/REA4020-01, Discount Drug Mart TRUE METRIX AIR Kit/REA4025-01, HEB TRUE METRIX AIR Kit/REA4031-01, SunmarkTRUE METRIX AIR Kit/REA4054-01, Rite AidTRUE METRIX AIR Kit/REA4066-01, Centerwell TRUE METRIX AIR Kit/REA4081-01, HumanaTRUE METRIX AIR Meter Only/REA4081-40, Centerwell TRUE METRIX AIR Starter Kit/REA4081-43, Healthmart TRUE METRIX AIR Kit/REA4089-01, Relion TRUE METRIX AIR Kit/REA4094-01, Relion TRUE METRIX AIR Kit/REA4094-01RX, Kroger TRUE METRIX AIR Kit/REA4203-01, Foster and Thrive TRUE METRIX AIR Kit/REA4211-01, TRUE METRIX AIR Kit/REA4H01-01, TRUE METRIX AIR NFRS Meter Only/REA4H01-40, TRUE METRIX AIR NFRS Starter Kit/REA4H01-43, TRUE METRIX AIR Kit (mg/dL)/REA4i03-01, TRUE METRIX AIR Starter Kit (mg/dL)/REA4i03-02, Walmart (MediMart) TRUE METRIX AIR Meter Only (Mexico - mg/dL)/REA4i04-00, TRUE METRIX AIR Kit (Australia - mmol/L)/REA4i81-11, TRUE METRIX AIR Kit (United Kingdom - mmol/L)/REA4i82-11, TRUE METRIX AIR Starter Kit (United Kingdom - mmol/L)/REA4i82-12 — Reason: The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose. — Status: Ongoing