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15,048 catalysts · 3,603 8k filing · 2,723 grant · 2,426 approval · 1,714 device 510k · 1,264 device recall · 1,172 device pma
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15,048 catalysts · 3,603 8k filing · 2,723 grant · 2,426 approval · 1,714 device 510k · 1,264 device recall · 1,172 device pma
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91 — Reason: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. — Status: Ongoing
Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344 — Reason: cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing. — Status: Ongoing
Product code: MQV. Advisory committee: Orthopedic. Type: Special
Product code: OBJ. Advisory committee: Cardiovascular. Type: Traditional
Product code: LLL. Advisory committee: Immunology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: PCH. Advisory committee: Microbiology. Type: Traditional
Product code: OUR. Advisory committee: Orthopedic. Type: Traditional
Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional
Product code: FMZ. Advisory committee: General Hospital. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Traditional
Product code: GAT. Advisory committee: General, Plastic Surgery. Type: Special
Product code: SCA. Advisory committee: Microbiology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Special
Product code: QJP. Advisory committee: Cardiovascular. Type: Special
Product code: QVF. Advisory committee: Microbiology. Type: Dual Track
Supplement type: 30-Day Notice. Product code: NIN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PQP. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Product code: QIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NXW. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: QWN. Advisory committee: CV. Decision: APPR
Supplement type: Special (Immediate Track). Product code: NIO. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MOM. 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: LWQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QBA. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QQK. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MNQ. Advisory committee: AN. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: OWD. Advisory committee: MG. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWQ. Advisory committee: CV. Decision: OK30
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing