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10,167 catalysts · 3,126 8k filing · 2,096 grant · 1,160 approval · 1,000 device adverse event · 874 device 510k · 623 device pma
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10,167 catalysts · 3,126 8k filing · 2,096 grant · 1,160 approval · 1,000 device adverse event · 874 device 510k · 623 device pma
Product code: LBI. Advisory committee: General Hospital. Type: Traditional
Product code: OUO. Advisory committee: Radiology. Type: Traditional
Product code: MYN. Advisory committee: Radiology. Type: Traditional
Product code: QHW. Advisory committee: Cardiovascular. Type: Traditional
Product code: BZD. Advisory committee: Anesthesiology. Type: Traditional
Product code: NRY. Advisory committee: Cardiovascular. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: SGY. Advisory committee: Gastroenterology, Urology. Type: Direct
Product code: PHX. Advisory committee: Orthopedic. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Special
Product code: QFG. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: PHX. Advisory committee: Orthopedic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Special
Product code: QEZ. Advisory committee: Cardiovascular. Type: Traditional
Product code: PSZ. Advisory committee: Microbiology. Type: Dual Track
Supplement type: 30-Day Notice. Product code: LMG. Advisory committee: SU. Decision: OK30
Supplement type: Panel Track. Product code: PQP. Advisory committee: PA. Decision: APPR
Supplement type: 30-Day Notice. Product code: LPB. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MJO. Advisory committee: OR. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: QZK. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: OAD. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MCN. Advisory committee: OB. Decision: OK30
Supplement type: 30-Day Notice. Product code: OAE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: OAD. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: OAE. Advisory committee: CV. Decision: OK30
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432 — Reason: Knee and Humeral socket implants contain incorrect labeling. — Status: Ongoing
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036 — Reason: Knee and Humeral socket implants contain incorrect labeling. — Status: Ongoing
Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/A — Reason: There is the potential for the length of the trocar shaft to be too long. — Status: Ongoing
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010 — Reason: Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine. — Status: Ongoing
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707 — Reason: Knee and Humeral socket implants contain incorrect labeling. — Status: Ongoing
AG grant. $293,454. PI: Caitlin R. Bowman
GM grant. $223,500. PI: KayLoni L. Olson
NS grant. $943,253. PI: Hideho Okada
DE grant. $699,184. PI: Sukirth Murthy Ganesan
AG grant. $466,125. PI: Valentina Mazzoli
AG grant. $476,159. PI: Martin Hruska
GM grant. $1. PI: Katherine Carmen Forbes
AG grant. $560,380. PI: Stephanie Grace Cone
AG grant. $690,865. PI: Alan A. Cohen
AG grant. $580,636. PI: Adriana San Miguel
AG grant. $446,875. PI: Eleonora Scorletti
DK grant. $676,279. PI: Javier Garcia Bermudez
AG grant. $642,063. PI: Jayeeta Basu
AG grant. $556,121. PI: Eric Lieberman Greer
NS grant. $186,250. PI: Jacques Wadiche
AG grant. $1,468,868. PI: ANNE BRUNET
Sponsor: ADC Therapeutics SA. Form: INJECTABLE. Route: INJECTION