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49 catalysts · 21 approval · 9 device 510k · 9 device recall · 7 device pma · 3 grant
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49 catalysts · 21 approval · 9 device 510k · 9 device recall · 7 device pma · 3 grant
Sponsor: GLAND. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: UPSHER SMITH LABS. Form: SUSPENSION/DROPS. Route: OTIC
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL
Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL
Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL
Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL
Sponsor: SANALUZ. Form: TABLET. Route: ORAL
Sponsor: STRIDES PHARMA INTL. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: NOVEL LABS INC. Form: SOLUTION. Route: ORAL
Sponsor: NOVEL LABS INC. Form: SOLUTION. Route: ORAL
Sponsor: NOVEL LABS INC. Form: SOLUTION. Route: ORAL
Sponsor: NOVEL LABS INC. Form: SOLUTION. Route: ORAL
Sponsor: SAREPTA THERAPS INC. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: GLAND. Form: POWDER. Route: INTRAVENOUS, SUBCUTANEOUS
Sponsor: KNACK. Form: INJECTABLE. Route: INJECTION
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: FMI. Advisory committee: General Hospital. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Special
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: PAY. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: PDJ. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: SGR. Advisory committee: Anesthesiology. Type: Traditional
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QNH. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Product code: QNH. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: PA. Decision: OK30
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System — Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. — Status: Ongoing
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System — Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. — Status: Ongoing
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System — Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. — Status: Ongoing
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System — Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. — Status: Ongoing
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System — Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. — Status: Ongoing
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System — Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. — Status: Ongoing
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System — Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. — Status: Ongoing
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM — Reason: The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown. — Status: Ongoing
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System — Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. — Status: Ongoing
DA grant. $49,538. PI: Lily Torp
NS grant. $74,632. PI: THADDEUS KUNKEL
NS grant. $50,000. PI: Huaye Zhang