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20,170 catalysts · 4,728 grant · 3,621 8k filing · 2,780 device 510k · 2,724 approval · 2,000 device recall · 1,959 device pma
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20,170 catalysts · 4,728 grant · 3,621 8k filing · 2,780 device 510k · 2,724 approval · 2,000 device recall · 1,959 device pma
Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1 — Reason: cGMP deviations — Status: Ongoing
Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07. — Reason: Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle. — Status: Ongoing
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33. — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit — Status: Ongoing
B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1002-2; b) Tint Free Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1001-2; c) Tan Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1003-2. — Reason: cGMP deviations — Status: Ongoing
In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingredients, Biodegradable & Baby Safe, 50 mL - 1.7 fl oz per bottle, Manufactured for IN YOUR FACE Skin Care, Belleair Bluffs, FL, Made in USA, NDC: 73369-1601-1 — Reason: cGMP deviations — Status: Ongoing
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MVK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIO. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Supplement type: Panel Track. Product code: NGV. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LOK. Advisory committee: IM. Decision: OK30
Supplement type: 30-Day Notice. Product code: NAF. Advisory committee: IM. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: QPT. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MTG. Advisory committee: IM. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVY. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: MVK. Advisory committee: CV. Decision: OK30
Pentax Medical Video Processor; Model Number: EPK-i8020c; — Reason: During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane. — Status: Ongoing
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889. — Reason: Potential for missing pins at tip of inserter. — Status: Ongoing
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system. — Reason: The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidentified as a different tip type, rendering it incompatible with the system and preventing use which causes a delay in obtaining patient results. — Status: Ongoing
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NQQ. Advisory committee: Radiology. Type: Traditional
Product code: FGE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ODC. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Special
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: GZF. Advisory committee: Neurology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: Special (Immediate Track). Product code: NIM. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30
Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A — Reason: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction — Status: Ongoing