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23,585 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,288 8k filing · 2,000 device pma · 2,000 device recall
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23,585 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,288 8k filing · 2,000 device pma · 2,000 device recall
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: KLA. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OAB. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: PLF. Advisory committee: Orthopedic. Type: Abbreviated
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: PNG. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KWS. Advisory committee: Orthopedic. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: FGE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LHI. Advisory committee: General Hospital. Type: Traditional
Product code: HSX. Advisory committee: Orthopedic. Type: Traditional
Product code: DQX. Advisory committee: Cardiovascular. Type: Special
Product code: OLV. Advisory committee: Neurology. Type: Traditional
Sponsor: NOVO. Form: TABLET. Route: ORAL
Sponsor: NOVO. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL
Product code: DYG. Advisory committee: Cardiovascular. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: HKI. Advisory committee: Ophthalmic. Type: Traditional
Product code: IZL. Advisory committee: Radiology. Type: Traditional
Product code: JEH. Advisory committee: Anesthesiology. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: QKB. Advisory committee: Radiology. Type: Traditional
Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: GENENTECH. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: IZL. Advisory committee: Radiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PSY. Advisory committee: Pathology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: DQX. Advisory committee: Cardiovascular. Type: Traditional
Product code: MWI. Advisory committee: Cardiovascular. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit — Status: Ongoing