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19,818 catalysts · 4,728 grant · 3,288 8k filing · 2,768 device 510k · 2,721 approval · 2,000 device recall · 1,955 device pma
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19,818 catalysts · 4,728 grant · 3,288 8k filing · 2,768 device 510k · 2,721 approval · 2,000 device recall · 1,955 device pma
Product code: BZR. Advisory committee: Anesthesiology. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Abbreviated
Product code: QEZ. Advisory committee: Cardiovascular. Type: Special
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Sponsor: SANDOZ. Form: EMULSION. Route: OPHTHALMIC
Supplement type: Normal 180 Day Track. Product code: NVZ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: QFV. Advisory committee: CV. Decision: APPR
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