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20,686 catalysts · 4,728 grant · 3,350 8k filing · 3,282 device 510k · 2,831 approval · 2,000 device pma · 2,000 device recall
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20,686 catalysts · 4,728 grant · 3,350 8k filing · 3,282 device 510k · 2,831 approval · 2,000 device pma · 2,000 device recall
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P. — Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met. — Status: Ongoing
3mensio Workstation (Vascular Fenestrated) software — Reason: When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage — Status: Ongoing
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Abbreviated
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