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13,283 catalysts · 3,603 8k filing · 2,377 grant · 2,049 approval · 1,383 device 510k · 1,000 device adverse event · 930 device pma
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13,283 catalysts · 3,603 8k filing · 2,377 grant · 2,049 approval · 1,383 device 510k · 1,000 device adverse event · 930 device pma
Product code: JXG. Advisory committee: Neurology. Type: Traditional
Product code: MEH. Advisory committee: Orthopedic. Type: Traditional
Product code: IMJ. Advisory committee: Physical Medicine. Type: Traditional
Product code: GZL. Advisory committee: Neurology. Type: Traditional
Product code: SFL. Advisory committee: MG. Decision: APPR
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. — Reason: Product testing did not meet expected stability criteria. — Status: Ongoing
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System — Reason: Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling. — Status: Ongoing
Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: PHATHOM. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION
Sponsor: PH HEALTH. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: HERITAGE PHARMA. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL RX. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: TEVA PHARMS INC. Form: POWDER. Route: SUBCUTANEOUS
Sponsor: TEVA PHARMS INC. Form: POWDER. Route: SUBCUTANEOUS
Sponsor: SANDOZ. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: STERISCIENCE. Form: INJECTABLE. Route: INJECTION
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Sponsor: SCIEGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: AMNEAL. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: HERITAGE PHARMA. Form: TABLET. Route: ORAL
Sponsor: INVAGEN PHARMS. Form: TABLET. Route: ORAL
Sponsor: ACTAVIS LABS FL INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: IZF. Advisory committee: Radiology. Type: Traditional
Product code: OXO. Advisory committee: Radiology. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Abbreviated
Product code: QAS. Advisory committee: Radiology. Type: Special
Product code: QFG. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: HBL. Advisory committee: Neurology. Type: Traditional
Product code: DXX. Advisory committee: Cardiovascular. Type: Traditional
Product code: KWS. Advisory committee: Orthopedic. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HBE. Advisory committee: Neurology. Type: Traditional
Product code: KLE. Advisory committee: Dental. Type: Traditional
Supplement type: Normal 180 Day Track No User Fee. Product code: MNQ. Advisory committee: AN. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: NQR. Advisory committee: NE. Decision: APPR
Supplement type: Real-Time Process. Product code: MKJ. Advisory committee: CV. Decision: APPR