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9,955 catalysts · 3,080 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma
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9,955 catalysts · 3,080 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma
Product code: KIF. Advisory committee: Dental. Type: Traditional
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: Panel Track. Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: MFK. Advisory committee: OP. Decision: OK30
Supplement type: Special (Immediate Track). Product code: NIO. Advisory committee: CV. Decision: APPR
Endo-Model Replacement Plateau; Item Number: 15-0027/11; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-8030/12; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-8521/15; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-0027/15; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-2835/12; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-2836/11; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-8521/09; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-8521/11; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-0027/12; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
Endo-Model Replacement Plateau; Item Number: 15-0027/16; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing
AI grant. $75,052. PI: Sarah C Feid
GM grant. $132,469. PI: Martha Rojo
HD grant. $248,995. PI: Thoa Khuu
NS grant. $579,610. PI: Pau Castel
HL grant. $469,049. PI: nagendra monangi
HL grant. $154,846. PI: HELAINE E. RESNICK
HL grant. $129,024. PI: DEDRA S BUCHWALD
AI grant. $87,244. PI: Jenny Ann Buczek
Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL
Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: AMNEAL. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION
Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION
Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL
Sponsor: ZYDUS LIFESCIENCES. Form: SUSPENSION. Route: ORAL
Product code: QNI. Advisory committee: Orthopedic. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Special
Product code: EJK. Advisory committee: Dental. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: MVK. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: PMP. Advisory committee: NE. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: LNM. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30