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21,418 catalysts · 4,728 grant · 3,700 8k filing · 3,538 device 510k · 2,904 approval · 2,000 device pma · 2,000 device recall
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21,418 catalysts · 4,728 grant · 3,700 8k filing · 3,538 device 510k · 2,904 approval · 2,000 device pma · 2,000 device recall
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 — Reason: Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil — Status: Ongoing
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01. — Reason: Presence of Foreign Tablets/Capsules — Status: Ongoing
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7 — Reason: Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. — Status: Ongoing
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313 — Reason: CGMP Deviations: product found to contain lead. — Status: Ongoing
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Special
Product code: OUR. Advisory committee: Orthopedic. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: QBP. Advisory committee: General Hospital. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: SHE. Advisory committee: Radiology. Type: Direct
Supplement type: 135 Review Track For 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMF. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: MRM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: DXY. Advisory committee: CV. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Product code: SHC. Advisory committee: SU. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: NPW. Advisory committee: CV. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: EZY. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: PNF. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MRM. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: MHY. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: OOB. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: Panel Track. Product code: PLS. Advisory committee: PA. Decision: APPR
Burlington Medical, Wrap Aprons. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Burlington Medical, Leg Wraps. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Burlington Medical, Half Aprons. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Burlington Medical, Vest — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Burlington Medical, Demi Half Aprons. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit — Reason: Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units — Status: Ongoing
Burlington Medical, Kilt Blockers. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; — Reason: The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct. — Status: Ongoing
Burlington Medical, Protective Sleeves. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing