calendar
8,028 catalysts · 3,603 8k filing · 1,346 grant · 1,000 device adverse event · 581 earnings · 550 approval · 430 device 510k
8,028 catalysts · 3,603 8k filing · 1,346 grant · 1,000 device adverse event · 581 earnings · 550 approval · 430 device 510k
Failure to Osseointegrate
Insufficient Information
Loss of or Failure to Bond; Naturally Worn
Fracture
Adverse Event Without Identified Device or Use Problem
Device Alarm System
Unable to Obtain Readings; Device Displays Incorrect Message
Adverse Event Without Identified Device or Use Problem
Difficult to Fold, Unfold or Collapse; Patient-Device Incompatibility
High Readings
Fracture
Failure to Osseointegrate
Patient Device Interaction Problem
Loss of Osseointegration
Adverse Event Without Identified Device or Use Problem
Material Rupture
Adverse Event Without Identified Device or Use Problem
Material Rupture
Adverse Event Without Identified Device or Use Problem
Loss of Osseointegration
Failure to Read Input Signal
Failure to Read Input Signal
Adverse Event Without Identified Device or Use Problem
Difficult to Advance; Device Dislodged or Dislocated
Fracture
DE grant. $44,984. PI: Prasun K Datta
DK grant. $34,272. PI: Rebekka Hannah Anderson
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: TARO PHARM INDS. Form: TABLET. Route: ORAL
Sponsor: TARO PHARM INDS. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: AKEBIA. Form: TABLET. Route: ORAL
Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: ELI LILLY AND CO. Form: TABLET. Route: ORAL
Sponsor: SOMERSET THERAPS LLC. Form: INJECTABLE. Route: INJECTION
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08. — Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. — Status: Ongoing
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44 — Reason: Subpotent Drug — Status: Ongoing
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08. — Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. — Status: Ongoing