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12,031 catalysts · 3,350 8k filing · 2,283 grant · 1,778 approval · 1,169 device 510k · 1,000 device adverse event · 849 device pma
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12,031 catalysts · 3,350 8k filing · 2,283 grant · 1,778 approval · 1,169 device 510k · 1,000 device adverse event · 849 device pma
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30
AlternatiV+ Screw-In Anchor — Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. — Status: Ongoing
Genesis Push-In Suture Anchor — Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. — Status: Ongoing
Fixone Biocomposite Anchor — Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. — Status: Ongoing
Fixone Hybrid Anchor — Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. — Status: Ongoing
Genesis Knotless Anchor — Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. — Status: Ongoing
AlternatiV+ Max Knotless Anchor — Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. — Status: Ongoing
Genesis Dual Thread Screw-In Anchor — Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. — Status: Ongoing
Genesis Screw-In Anchor — Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. — Status: Ongoing
GM grant. $291,000. PI: Hui Hong
Sponsor: COSETTE. Form: TABLET. Route: ORAL
Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL
Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL
Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL
Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL
Sponsor: SOLARIS PHARMA CORP. Form: OINTMENT. Route: INTRA-ANAL
Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: SUBLINGUAL
Sponsor: CHENGDU SHUODE. Form: INJECTABLE. Route: INJECTION
Sponsor: FORMYCON AG. Form: INJECTION
Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL
Sponsor: MICRO LABS. Form: TABLET. Route: ORAL
Sponsor: CREEKWOOD PHARMS. Form: TABLET. Route: ORAL
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: PKL. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FDX. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LIT. Advisory committee: Cardiovascular. Type: Traditional
Product code: KDI. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: MXK. Advisory committee: Ophthalmic. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional
Product code: HIH. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: OLR. Advisory committee: Unknown. Type: Special
Product code: PND. Advisory committee: General Hospital. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Traditional
Product code: QVA. Advisory committee: Radiology. Type: Traditional
Product code: MXD. Advisory committee: Cardiovascular. Type: Special
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Supplement type: 30-Day Notice. Product code: PNF. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: MRM. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LPC. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: MRM. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: OTL. Advisory committee: OP. Decision: APPR
Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NGV. Advisory committee: CV. Decision: OK30