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21,783 catalysts · 4,728 grant · 4,110 device 510k · 3,189 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall
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21,783 catalysts · 4,728 grant · 4,110 device 510k · 3,189 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall
Product code: NRY. Advisory committee: Cardiovascular. Type: Traditional
Product code: QQX. Advisory committee: Microbiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: BSO. Advisory committee: Anesthesiology. Type: Traditional
Product code: OBP. Advisory committee: Neurology. Type: Traditional
Product code: ELC. Advisory committee: Dental. Type: Traditional
Product code: QZA. Advisory committee: General Hospital. Type: Special
Sponsor: DECIPHERA PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION
Product code: QOF. Advisory committee: Microbiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Special
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MMX. Advisory committee: Cardiovascular. Type: Special
Product code: QAS. Advisory committee: Radiology. Type: Special
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: MRH. Advisory committee: General Hospital. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MWI. Advisory committee: Cardiovascular. Type: Traditional
Product code: FLL. Advisory committee: General Hospital. Type: Traditional
Product code: POK. Advisory committee: Radiology. Type: Traditional
Product code: OAS. Advisory committee: Radiology. Type: Traditional
Product code: GWN. Advisory committee: Neurology. Type: Traditional
Product code: POM. Advisory committee: Neurology. Type: Traditional
Sponsor: ACCORD HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: PFIZER. Form: TABLET. Route: ORAL
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Product code: HIS. Advisory committee: Obstetrics/Gynecology. Type: Abbreviated
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: OMP. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Sponsor: ELITE LABS INC. Form: TABLET. Route: ORAL
Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: ORAL
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15 — Reason: Out of Specification for Dissolution — Status: Ongoing
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Dual Track
Product code: EIA. Advisory committee: Dental. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional
Product code: OWN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: OWT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KCT. Advisory committee: General Hospital. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional