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14,231 catalysts · 3,313 8k filing · 2,402 grant · 2,350 approval · 1,681 device 510k · 1,204 device recall · 1,151 device pma
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14,231 catalysts · 3,313 8k filing · 2,402 grant · 2,350 approval · 1,681 device 510k · 1,204 device recall · 1,151 device pma
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
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned on the catheter inside the balloon that define the working length — Reason: Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit. — Status: Ongoing
Multichem ID-B. Model 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 13 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing
IntelePACS - InteleConnect / TechPortal — Reason: Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making. — Status: Ongoing
MONARCH Bronchoscope. Model Number: MBR-000211-B — Reason: Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks. — Status: Ongoing
Sponsor: ASTRAZENECA AB. Form: INJECTABLE. Route: INJECTION
Sponsor: MICRO LABS. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: NOVARTIS. Form: TABLET. Route: ORAL
Product code: DSY. Advisory committee: Cardiovascular. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: ONG. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional