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19,968 catalysts · 4,728 grant · 3,674 8k filing · 2,705 approval · 2,642 device 510k · 2,000 device recall · 1,873 device pma
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19,968 catalysts · 4,728 grant · 3,674 8k filing · 2,705 approval · 2,642 device 510k · 2,000 device recall · 1,873 device pma
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: ALKEM LABS LTD. Form: TABLET. Route: ORAL
Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS USA INC. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: WATSON LABS. Form: TABLET. Route: ORAL
Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: GE HEALTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: GE HEALTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: GE HEALTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: GE HEALTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: TORRENT. Form: CAPSULE
Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: SUBLINGUAL
Sponsor: DAIICHI SANKYO. Form: INJECTABLE. Route: INJECTION
Sponsor: DAIICHI SANKYO. Form: INJECTABLE. Route: INJECTION
Sponsor: SANDOZ. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: NOVEL LABS INC. Form: TABLET. Route: ORAL
Sponsor: NOVEL LABS INC. Form: TABLET. Route: ORAL
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: NQQ. Advisory committee: Radiology. Type: Traditional
Product code: KRD. Advisory committee: Cardiovascular. Type: Special
Product code: KRO. Advisory committee: Orthopedic. Type: Traditional
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: LKF. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: OQB. Advisory committee: Orthopedic. Type: Traditional
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QSY. Advisory committee: Unknown. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Special
Product code: BZD. Advisory committee: Anesthesiology. Type: Traditional
Product code: OLI. Advisory committee: General, Plastic Surgery. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: MVC. Advisory committee: PA. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: SEG. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: NGV. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: QXB. Advisory committee: GU. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: NGV. Advisory committee: CV. Decision: APPR
Product code: SGV. Advisory committee: SU. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: NYQ. Advisory committee: PA. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: SDK. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: ONV. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30
Estrone RIA, REF: DSL8700 — Reason: The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur. — Status: Ongoing
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box) — Reason: Access Port System tray may develop cracks potentially resulting in a sterility breach. — Status: Ongoing