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12,103 catalysts · 3,603 8k filing · 2,280 grant · 1,746 approval · 1,120 device 510k · 1,000 device adverse event · 821 device pma
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12,103 catalysts · 3,603 8k filing · 2,280 grant · 1,746 approval · 1,120 device 510k · 1,000 device adverse event · 821 device pma
Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair, Catalog Number Z360 UDI-DI code: (01)00628758003601 Raz-SP (Self Propel) Mobile Shower Commode Chair, Catalog Number Z200 UDI-DI code: (01)00628758001003 Raz-AP (Attendant Propel) Mobile Shower Commode Chair, Catalog Number Z100 UDI-DI code: (01)00628758001003 The Raz Mobile Shower Commode Chair is intended to be used by people with mobility impairments, who may have difficulty in standing or keeping their balance while completing activities such as showering, toileting, or personal hygiene. — Reason: Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place. — Status: Ongoing
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528 — 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
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