calendar
9,058 catalysts · 3,392 8k filing · 1,730 grant · 1,000 device adverse event · 818 approval · 626 device 510k · 584 earnings
9,058 catalysts · 3,392 8k filing · 1,730 grant · 1,000 device adverse event · 818 approval · 626 device 510k · 584 earnings
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786 — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing
COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242 — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing
Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252 — Reason: Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system. — Status: Ongoing
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686. — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775 — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing
COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115. — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing
COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251. — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing
COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791 — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing
COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537. — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing
COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G34914; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0047, Order Number G44431; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, Order Number G44432. — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing
COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073 — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing
Vue Motion V12. Product Number: 1017979. — Reason: Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence. — Status: Ongoing
GM grant. $409,941. PI: Aaron Harvey Morris
MH grant. $442,750. PI: Lauren Marie Schaefer
HL grant. $44,751. PI: Abhishek Vijay Thakkar
CA grant. $550,210. PI: Shawn Hingtgen
GM grant. $406,112. PI: Jie Sun
GM grant. $406,026. PI: Yaojun Zhang
GM grant. $432,569. PI: Simou Sun
EB grant. $662,737. PI: Yanliang Zhang
DC grant. $2,387,184. PI: JACK M FLETCHER
MH grant. $208,794. PI: Emily Lauren Tilstra-Ferrell
DE grant. $555,081. PI: Christina Scherrer
MH grant. $445,816. PI: Jennifer Blumenthal-Barby
GM grant. $123,687. PI: Owen Funk
MH grant. $843,322. PI: Ragy Ramsis Girgis
AG grant. $214,223. PI: Robert Edward Burke
OD grant. $434,110. PI: Jenni Shearston
MH grant. $710,563. PI: Christine M Constantinople
GM grant. $433,125. PI: Amy C Rowat
GM grant. $449,625. PI: Samagya Banskota
DK grant. $655,482. PI: VIKAS DUDEJA
NS grant. $75,880. PI: Christopher David Adam
MH grant. $641,828. PI: Hume Akahori Stroud
AG grant. $121,239. PI: Mara Getz Sheftel
MH grant. $820,196. PI: Stephen P Becker
MH grant. $779,797. PI: Rainbo Hultman
NS grant. $555,265. PI: Emily Rose Petrus
MH grant. $659,242. PI: Hyman Scott
DC grant. $124,686. PI: Eleonora Judith Beier
MH grant. $156,500. PI: Santiago Jose Arconada Alvarez
GM grant. $445,983. PI: Mark A PERRELLA
GM grant. $429,000. PI: Lauren Elizabeth Surface
GM grant. $407,603. PI: Grayson Oren Sipe
NS grant. $602,065. PI: J. Marc Simard
Sponsor: ABBVIE INC. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ABBVIE INC. Form: INJECTABLE. Route: INJECTION
Sponsor: UPSHER SMITH LABS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: APHELION. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL