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17,936 catalysts · 4,728 grant · 3,603 8k filing · 2,587 approval · 1,933 device 510k · 1,543 device recall · 1,343 device pma
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17,936 catalysts · 4,728 grant · 3,603 8k filing · 2,587 approval · 1,933 device 510k · 1,543 device recall · 1,343 device pma
Sponsor: GLENMARK PHARMS LTD. Form: CAPSULE. Route: ORAL
Product code: SGH. Advisory committee: Radiology. Type: Traditional
Product code: QHA. Advisory committee: Radiology. Type: Traditional
Product code: MHX. Advisory committee: Cardiovascular. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: DQX. Advisory committee: Cardiovascular. Type: Traditional
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ODC. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: JZO. Advisory committee: Immunology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: SGG. Advisory committee: Immunology. Type: Traditional
Product code: SFW. Advisory committee: Gastroenterology, Urology. Type: Direct
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Product code: PLF. Advisory committee: Orthopedic. Type: Traditional
Product code: OBR. Advisory committee: Unknown. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: NFO. Advisory committee: Neurology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Abbreviated
Product code: HCG. Advisory committee: Neurology. Type: Special
Supplement type: 30-Day Notice. Product code: NPS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NKM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PFV. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PRL. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: MKT. Advisory committee: MI. Decision: APPR
Supplement type: 30-Day Notice. Product code: QPT. Advisory committee: GU. Decision: OK30
Supplement type: Real-Time Process. Product code: MAQ. Advisory committee: MI. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: 30-Day Notice. Product code: OAD. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: 30-Day Notice. Product code: OAD. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: APPR
Product code: LOM. Advisory committee: MI. Decision: APRL
Supplement type: Real-Time Process. Product code: MKT. Advisory committee: MI. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: LOM. Advisory committee: MI. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LPB. Advisory committee: CV. Decision: OK30
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG. — Reason: Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform. — Status: Ongoing
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing
BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide — Reason: If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated. — Status: Ongoing
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10; — Reason: The possibility for this product that is intended for demonstration purposes only to be placed in patients. — Status: Ongoing