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12,251 catalysts · 3,603 8k filing · 2,283 grant · 1,771 approval · 1,164 device 510k · 1,000 device adverse event · 848 device pma
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12,251 catalysts · 3,603 8k filing · 2,283 grant · 1,771 approval · 1,164 device 510k · 1,000 device adverse event · 848 device pma
Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7 — Reason: Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products. — Status: Ongoing
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 — Reason: 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery. — Status: Ongoing
Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7 — Reason: Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products. — Status: Ongoing
Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1 — Reason: Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products. — Status: Ongoing
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C — Reason: 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery. — Status: Ongoing
Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214 — Reason: Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products. — Status: Ongoing
NS grant. $33,538. PI: SEAN COLLIER
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