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23,450 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,153 8k filing · 2,000 device pma · 2,000 device recall
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23,450 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,153 8k filing · 2,000 device pma · 2,000 device recall
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: JAQ. Advisory committee: Radiology. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional
Product code: MQB. Advisory committee: Radiology. Type: Traditional
Product code: PCH. Advisory committee: Microbiology. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MQP. Advisory committee: Orthopedic. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: QBS. Advisory committee: Radiology. Type: Traditional
Product code: PBF. Advisory committee: Orthopedic. Type: Traditional
Sponsor: DEXCEL PHARMA. Form: TABLET, DELAYED RELEASE. Route: ORAL
Product code: QDQ. Advisory committee: Radiology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Traditional
Product code: MLO. Advisory committee: Cardiovascular. Type: Traditional
Product code: PLF. Advisory committee: Orthopedic. Type: Special
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional
Product code: NGL. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: KLE. Advisory committee: Dental. Type: Traditional
Product code: ODC. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: QXU. Advisory committee: Cardiovascular. Type: Special
Product code: NHA. Advisory committee: Dental. Type: Traditional
Sponsor: SOBI. Form: CAPSULE. Route: ORAL
Product code: DQO. Advisory committee: Cardiovascular. Type: Traditional
Product code: EFB. Advisory committee: Dental. Type: Traditional
Product code: SDC. Advisory committee: General Hospital. Type: Direct
Product code: MQB. Advisory committee: Radiology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: CCK. Advisory committee: Anesthesiology. Type: Traditional
Product code: NDC. Advisory committee: Anesthesiology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: DRG. Advisory committee: Cardiovascular. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: FED. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FXX. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: GILEAD SCIENCES INC. Form: TABLET. Route: ORAL
Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: ORAL
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. — Reason: Crystallization — Status: Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05. — Reason: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle — Status: Ongoing