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17,746 catalysts · 4,639 grant · 3,603 8k filing · 2,587 approval · 1,903 device 510k · 1,500 device recall · 1,315 device pma
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17,746 catalysts · 4,639 grant · 3,603 8k filing · 2,587 approval · 1,903 device 510k · 1,500 device recall · 1,315 device pma
Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-101 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-105 - Gluteal Implant style 1 size 5 UDI-DI code: B490501105 501-206 - Gluteal Implant style 2 size 6 UDI-DI code: B490501206 501-301 - Gluteal Implant style 3 size 1 UDI-DI code: B490501301 501-302 - Gluteal Implant style 3 size 2 UDI-DI code: B490501302 501-303 - Gluteal Implant style 3 size 3 UDI-DI code: B490501303 501-304 - Gluteal Implant style 3 size 4 UDI-DI code: B490501304 501-305 - Gluteal Implant style 3 size 5 UDI-DI code: B490501305 501-306 - Gluteal Implant style 3 size 6 UDI-DI code: B490501306 501-307 - Gluteal Implant style 3 size 7 UDI-DI code: B490501307 501-309 - Gluteal Implant style 3 size 9 UDI-DI code: B490501309 501-310 - Gluteal Implant style 3 size 10 UDI-DI code: B490501310 — Reason: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. — Status: Ongoing
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7250 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
AA grant. $585,577. PI: Alexandre Esteves Medina
AR grant. $129,035. PI: Christine Chieko Yokoyama
AI grant. $4,627. PI: CHLOE L THIO
AI grant. $3,559,750. PI: Magnus Adrian Gero Hoffmann
HL grant. $4,221,341. PI: REBEKAH NEAL
AG grant. $43,727. PI: Kayla Victoria McNeely
HD grant. $426,375. PI: ANDREW S MCCALLION
NR grant. $695,209. PI: Bushra Sabri
AA grant. $188,313. PI: KRISTIN M HAMRE
AA grant. $49,538. PI: Elena Kalina
NR grant. $783,321. PI: Karen Alexander
DA grant. $401,373
ES grant. $780,173. PI: Theresa M Bastain
HD grant. $156,500. PI: YUSUKE MARIKAWA
AI grant. $304,838. PI: Nicole J. Shirkey-Son
NR grant. $542,373. PI: Rachel Kuperman
AA grant. $548,014. PI: Adrian Rothenfluh
NR grant. $771,304. PI: Ifeyinwa Valerie Asiodu
AA grant. $219,938. PI: Shengmin Yan
HD grant. $264,600. PI: Diego A. Diaz-Faes
HD grant. $20,000. PI: Monika A Ward
ES grant. $1. PI: Theresa M Bastain
NR grant. $733,679. PI: Kartik Kailas Venkatesh
HG grant. $633,116. PI: Benedict Paten
NR grant. $626,456. PI: Jennifer Rai Richards
HL grant. $4,601,971
HL grant. $4,351,500
HD grant. $413,509. PI: Tengfei Li
HD grant. $418,123. PI: MARK Adam MCGUIRE
AG grant. $43,728. PI: Paul Benjamin Vander
LM grant. $472,500. PI: Lei Wang
HL grant. $1,553,202. PI: PETER RATH
HL grant. $3,918,561. PI: Andrew Patrick Ambrosy
LM grant. $446,800. PI: GORDON J HARRIS
ES grant. $100,000. PI: Aitor Aguirre
LM grant. $529,500. PI: Alexander L Greninger
HL grant. $891,834
LM grant. $462,000. PI: Hunter Nathaniel Moseley
LM grant. $462,000. PI: Mark A Musen
LM grant. $582,435. PI: Oliver Ruebel
Sponsor: AMNEAL PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: NOVEL LABS INC. Form: TABLET. Route: ORAL
Sponsor: NOVEL LABS INC. Form: TABLET. Route: ORAL
MH grant. $78,052. PI: Elizabeth Wenzel
HD grant. $42,895. PI: Eden Winslow
Sponsor: ZYDUS PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS USA INC. Form: TABLET, FOR SUSPENSION. Route: ORAL