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10,300 catalysts · 3,230 8k filing · 2,097 grant · 1,166 approval · 1,000 device adverse event · 881 device 510k · 629 device pma
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10,300 catalysts · 3,230 8k filing · 2,097 grant · 1,166 approval · 1,000 device adverse event · 881 device 510k · 629 device pma
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
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: ACCORD HLTHCARE. Form: TABLET. Route: ORAL
Sponsor: HEBEI CHANGSHAN. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL
Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: HUMANWELL. Form: TABLET. Route: ORAL
Sponsor: HUMANWELL. Form: TABLET. Route: ORAL
Sponsor: MYLAN. Form: TABLET. Route: ORAL-28
Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL
Sponsor: INNOGENIX. Form: TABLET. Route: ORAL
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10 — Reason: Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. — Status: Ongoing
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13 — Reason: Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale. — Status: Ongoing
Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14 — Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe — Status: Ongoing
Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14 — Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe — Status: Ongoing
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29 — Reason: Lack of Assurance of Sterlity — Status: Ongoing
Product code: KIF. Advisory committee: Dental. Type: Traditional
Product code: QAU. Advisory committee: General, Plastic Surgery. Type: Special
Product code: PHN. Advisory committee: Unknown. Type: Special
Product code: MYN. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: BZD. Advisory committee: Anesthesiology. Type: Special