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9,361 catalysts · 3,230 8k filing · 2,029 grant · 1,000 device adverse event · 897 approval · 659 device 510k · 584 earnings
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9,361 catalysts · 3,230 8k filing · 2,029 grant · 1,000 device adverse event · 897 approval · 659 device 510k · 584 earnings
Supplement type: 135 Review Track For 30-Day Notice. Product code: DYE. Advisory committee: CV. Decision: APPR
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use — Reason: Probes may rupture/burst during activation — Status: Ongoing
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use — Reason: Probes may rupture/burst during activation — Status: Ongoing
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. — Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. — Status: Ongoing
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140. — Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. — Status: Ongoing
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. — Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. — Status: Ongoing
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444. — Reason: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. — Status: Ongoing
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use — Reason: Probes may rupture/burst during activation — Status: Ongoing
TW grant. $372,306. PI: Farrah Jasmine Mateen
GM grant. $191,972. PI: June Bryan de la Pena
AI grant. $407,326. PI: STEPHEN C JAMESON
GM grant. $423,734. PI: Nir Yakoby
Sponsor: ZYDUS LIFESCIENCES. Form: GEL. Route: TOPICAL
Sponsor: AVYXA HOLDINGS. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: HQ SPCLT PHARMA. Form: POWDER. Route: INTRAVENOUS
Sponsor: HARMONY. Form: TABLET. Route: ORAL
Sponsor: UNICHEM. Form: TABLET. Route: ORAL
Sponsor: UNICHEM. Form: TABLET. Route: ORAL
Sponsor: WA UNIV SCH MED. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: JANSSEN BIOTECH. Form: VIAL. Route: SINGLE-USE
Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: AOP HLTH US. Form: POWDER. Route: INTRAVENOUS
Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Product code: DXQ. Advisory committee: Cardiovascular. Type: Traditional
Product code: OLX. Advisory committee: Neurology. Type: Special
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: LIT. Advisory committee: Cardiovascular. Type: Traditional
Product code: OCW. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Dual Track
Product code: DXG. Advisory committee: Cardiovascular. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: CBI. Advisory committee: Anesthesiology. Type: Traditional
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OLI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: FMZ. Advisory committee: General Hospital. Type: Traditional
Product code: DXH. Advisory committee: Cardiovascular. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: OWN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GXI. Advisory committee: Neurology. Type: Traditional
Product code: DXT. Advisory committee: Cardiovascular. Type: Traditional
Product code: MOF. Advisory committee: Cardiovascular. Type: Special
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30