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19,256 catalysts · 4,728 grant · 3,288 8k filing · 2,681 approval · 2,488 device 510k · 2,000 device recall · 1,743 device pma
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19,256 catalysts · 4,728 grant · 3,288 8k filing · 2,681 approval · 2,488 device 510k · 2,000 device recall · 1,743 device pma
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PRC. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: MHY. Advisory committee: NE. Decision: APPR
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034 — Reason: Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur. — Status: Ongoing
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04. — Reason: Inconsistent size terminology and color coding used on labeling — Status: Ongoing
Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15. — Reason: Inconsistent size terminology and color coding used on labeling — Status: Ongoing
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: DXQ. Advisory committee: Cardiovascular. Type: Traditional
Product code: QYE. Advisory committee: Cardiovascular. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: OXH. Advisory committee: General, Plastic Surgery. Type: Special
Product code: LCX. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: KXK. Advisory committee: Radiology. Type: Traditional
Product code: QUW. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION
Sponsor: ABBVIE INC. Form: VIAL
Sponsor: AZURITY. Form: TABLET. Route: ORAL
GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free, Biodegradable, Chemical Free, Non-Nano, Baby Safe, Original, SPF 32, Totally Green personal care, Zinc Oxide USP 25%, 3.4 FL OZ/115 G Tube, NDC: 73369-0001-1 — Reason: cGMP deviations — Status: Ongoing
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