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8,400 catalysts · 3,415 8k filing · 1,458 grant · 1,000 device adverse event · 701 approval · 582 earnings · 540 device 510k
8,400 catalysts · 3,415 8k filing · 1,458 grant · 1,000 device adverse event · 701 approval · 582 earnings · 540 device 510k
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ANGIO PACK, Medline SKU # DYNJ57032D; 2. NEURO INTERVENTIONAL RADIOLOGY, Medline SKU # DYNJ64026C; 3. NEURO INERVENTIONAL RADIOLOGY, Medline SKU # VASC1650. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. SHOULDER ARTHROSCOPY PACK, Medline SKU # DYNJ30880M; 2. EXTREMITY PACK, Medline SKU # DYNJ64295A. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. HEAD AND NECK CDS-LF, Medline SKU # CDS780138K; 2. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 3. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 4. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 5. THYROIDECTOMY, Medline SKU # DYNJ910458; 6. LH 3 PORT W/O WASTEBAG, Medline SKU # VASC1081C; 7. LHK, Medline SKU # VASC1510; 8. LHK, Medline SKU # VASC1510. — Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. — Status: Ongoing
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor — Reason: Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload. — Status: Ongoing
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777 — Reason: The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes. — Status: Ongoing
GM grant. $205,995. PI: ROSANA BARRETO ROCHA FERREIRA
DK grant. $780,220. PI: YU KUEI LIN
DA grant. $50,196. PI: Yash Dinesh Agarwal
Supplement type: 30-Day Notice. Product code: SAZ. Advisory committee: NE. Decision: OK30
AG grant. $51,492. PI: Julie J. McInvale
TW grant. $124,785. PI: SEYDOU DOUMBIA
HD grant. $249,000. PI: Vanessa Babineau
MH grant. $1,479,470. PI: Steven A Schaffert
TW grant. $616,000. PI: Henna Budhwani
GM grant. $537,696. PI: VALERIE J REINKE
GM grant. $425,667. PI: Jean-Paul Armache
GM grant. $494,796. PI: James Spudich
GM grant. $412,373. PI: Eric R Brooks
DA grant. $41,789. PI: Jordan Cook
DA grant. $37,108. PI: Charles N Zawatsky
DA grant. $9,880. PI: Nii A Addy
NR grant. $57,538. PI: Rebecca Singer Cohen
AI grant. $80,020. PI: Colin Richard Gliech
HL grant. $38,922. PI: Claire Fleming
GM grant. $434,212. PI: Tatiana Moiseeva
GM grant. $613,838. PI: SUSAN M PARKHURST
GM grant. $333,290. PI: Eric F Lock
GM grant. $446,219. PI: Hosea Martin Nelson
MH grant. $871,225. PI: Joshua Sarfaty Siegel
DK grant. $154,332. PI: Mi Jeong Heo
DA grant. $239,125. PI: Lieselot Leen Georges Carrette
DA grant. $683,782. PI: Kenneth Tucker Kishida
AG grant. $458,622. PI: Christine Ann Denny
DK grant. $770,603. PI: Laura C Alonso
DK grant. $394,296. PI: GABRIELA E GARCIA
DE grant. $735,436. PI: Xiao Zhao
HL grant. $1,151,498. PI: Jianwen Que
GM grant. $1,601,098. PI: Jacob L Mueller
DK grant. $716,069. PI: Elizabeth Ann Suarez
DK grant. $782,459. PI: ZHENQI LIU
DA grant. $1,387,755. PI: Christine Cheng
AG grant. $209,690. PI: David H. Lynch
DK grant. $746,950. PI: Anum Azam Glasgow
GM grant. $76,780. PI: Kelsie Elizabeth Hunnicutt
GM grant. $46,415. PI: Isha Walawalkar
NS grant. $49,538. PI: Nichole Yakas
DA grant. $197,640. PI: John J Chiosi
AG grant. $1,732,842. PI: Kelly Bakulski
TW grant. $124,196. PI: SEYDOU DOUMBIA
HL grant. $49,538. PI: Lauren Ayers