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58 catalysts · 26 device 510k · 19 approval · 6 device pma · 4 device recall · 3 grant
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58 catalysts · 26 device 510k · 19 approval · 6 device pma · 4 device recall · 3 grant
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: POWDER. Route: IV (INFUSION)
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: GRANULES. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL
Sponsor: CHARTWELL. Form: SOLUTION. Route: ORAL
Sponsor: PH HEALTH. Form: SOLUTION. Route: ORAL
Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION
Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL
Sponsor: TELIX. Form: POWDER. Route: INTRAVENOUS
Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: SHREE HARI INTL. Form: SYRUP. Route: ORAL
Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: INSMED INC. Form: SUSPENSION, LIPOSOMAL. Route: INHALATION
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: NPL. Advisory committee: Dental. Type: Traditional
Product code: QKB. Advisory committee: Radiology. Type: Traditional
Product code: FAS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Special
Product code: ONB. Advisory committee: General Hospital. Type: Special
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: MQC. Advisory committee: Unknown. Type: Traditional
Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional
Product code: FFX. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DXH. Advisory committee: Cardiovascular. Type: Traditional
Product code: KLE. Advisory committee: Dental. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Traditional
Product code: MYE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: PBF. Advisory committee: Orthopedic. Type: Traditional
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: KXK. Advisory committee: Radiology. Type: Traditional
Product code: JTN. Advisory committee: Microbiology. Type: Traditional
Product code: BZD. Advisory committee: Anesthesiology. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: OAD. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: LPM. Advisory committee: OP. Decision: APPR
Supplement type: Real-Time Process. Product code: MIH. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30
Supplement type: 30-Day Notice. Product code: MDS. Advisory committee: CH. Decision: OK30