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12,161 catalysts · 3,603 8k filing · 2,283 grant · 1,765 approval · 1,146 device 510k · 1,000 device adverse event · 827 device pma
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12,161 catalysts · 3,603 8k filing · 2,283 grant · 1,765 approval · 1,146 device 510k · 1,000 device adverse event · 827 device pma
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc — Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. — Status: Ongoing
Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc — Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. — Status: Ongoing
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system. — Reason: Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use. — Status: Ongoing
Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package — Reason: Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals. — Status: Ongoing
Sterile Radiology Procedure Kits, Model Number DYNDH1491B — Reason: There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility. — Status: Ongoing
AI grant. $797,087. PI: Job E Lopez
MH grant. $193,320. PI: Julianne G. Wilner
AI grant. $583,909. PI: XUE HAN
AI grant. $566,875. PI: Changlu Liu
AI grant. $10,000. PI: DAVID J. STEWART
ES grant. $929,307. PI: Jodi A. Flaws
AI grant. $190,804. PI: Alexander Hoffmann
DK grant. $125,250. PI: Yelba Castellon-Lopez
AI grant. $779,825. PI: Paul Garrity
AI grant. $496,628. PI: RANDALL S DAVIS
AI grant. $392,142. PI: Jamal S Lewis
AI grant. $393,217. PI: Reza Ghodssi
AI grant. $479,610. PI: Oren Levy
NS grant. $15,000. PI: Simon Scheuring
AI grant. $420,063. PI: Brian Stevenson
DK grant. $782,886. PI: Katrin Jennifer Svensson
AI grant. $423,500. PI: Sourav Ghosh
AI grant. $445,000. PI: David M. Briscoe
DK grant. $817,498. PI: STEPHEN ROBERT FARMER
HL grant. $248,679. PI: Xiangqin He
DK grant. $802,015. PI: Steve Davidson
NR grant. $424,897. PI: Amanda Emerson
CA grant. $8,000. PI: Shan Zha
DK grant. $811,217. PI: Alan D Cherrington
Sponsor: PFIZER INC. Form: SOLUTION. Route: INJECTION
Sponsor: AVET LIFESCIENCES. Form: INJECTABLE. Route: INJECTION
Sponsor: MSN. Form: SOLUTION. Route: ORAL
Sponsor: KYOWA KIRIN. Form: INJECTABLE. Route: INJECTION
Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL
Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS
Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL
Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL
Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL
Sponsor: ABBVIE. Form: TABLET. Route: ORAL
Product code: PLF. Advisory committee: Orthopedic. Type: Traditional
Product code: NHN. Advisory committee: Physical Medicine. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: GAT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QAI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Special
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: FXX. Advisory committee: General, Plastic Surgery. Type: Special
Product code: SEI. Advisory committee: Microbiology. Type: Traditional
Product code: EHD. Advisory committee: Dental. Type: Traditional