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14,268 catalysts · 3,350 8k filing · 2,402 grant · 2,350 approval · 1,681 device 510k · 1,204 device recall · 1,151 device pma
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14,268 catalysts · 3,350 8k filing · 2,402 grant · 2,350 approval · 1,681 device 510k · 1,204 device recall · 1,151 device pma
IntelliVue Patient Monitor MX600. Product Number: 865242. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
Stryker Arise 1000EX mattress, Part Number 2236000000 — Reason: Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker. — Status: Ongoing
Stryker MV3 bariatric bed, Part Number 5900000001 — Reason: Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker. — Status: Ongoing
IntelliVue Patient Monitor MX400. Product Number: 866060. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
IntelliVue Multi-Measurement Module X3. Product Number: 867030. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
Olympus OER-Pro — Reason: Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance. — Status: Ongoing
IntelliVue Patient Monitor MX550. Product Number: 866066. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
IntelliVue Patient Monitor MX750. Product Number: 866471. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
Olympus OER-Mini — Reason: Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance. — Status: Ongoing
IntelliVue Patient Monitor MX450. Product Number: 866062. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber — Reason: Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction. — Status: Ongoing
IntelliVue MP70. Product Number: M8007A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
AI grant. $38,093. PI: Maureen E Hoen Rauhut
AI grant. $34,558. PI: Yona Lei
AI grant. $78,052. PI: Shea Lowery
MH grant. $33,538. PI: Elinor Lewis
AI grant. $75,520. PI: Nicholas Cauldron
AI grant. $19,000. PI: JASON B HARRIS
MH grant. $42,489. PI: Naomi Gancz
AI grant. $49,538. PI: Hadley Beauregard
AI grant. $44,020. PI: Tierra Buck
MH grant. $75,052. PI: Manasi Iyer
AI grant. $99,429. PI: JASON B HARRIS
HD grant. $75,600. PI: Michelle H Chen
AI grant. $238,136. PI: Jeffrey David Klausner
DK grant. $103,081. PI: Brittany L. Smalls
AI grant. $53,461. PI: Danielle Rose Jacobsen
AI grant. $49,538. PI: Jacob D Sherman
OD grant. $2,500,000. PI: Melissa Basford
NS grant. $245,687. PI: Sara J Hussain
AI grant. $85,360. PI: Kurtis Matthew Host
AI grant. $103,760. PI: Conor James McMeniman
DK grant. $20,000. PI: FOUAD R KANDEEL
AI grant. $48,395. PI: Isabel Lamb-Echegaray
AI grant. $75,520. PI: Shyra Wilde
AI grant. $75,052. PI: Rachel Lucy Fay
Supplement type: Normal 180 Day Track No User Fee. Product code: OUT. Advisory committee: NE. Decision: APPR
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values. — Reason: A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery. — Status: Ongoing
Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: HOSPIRA INC. Form: INJECTABLE. Route: INJECTION
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: DR REDDYS. Form: TABLET. Route: ORAL
Sponsor: DR REDDYS. Form: TABLET. Route: ORAL
Sponsor: MYLAN. Form: TABLET. Route: ORAL
Sponsor: MSN. Form: TABLET. Route: ORAL
Sponsor: MSN. Form: TABLET. Route: ORAL
Sponsor: SPH ZHONGXI PHARM. Form: TABLET. Route: ORAL