12 results
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6ms
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Sources: EU EUDAMED, US FDA
XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT QUICK CONNECT USB, 41000-030-53; e) XSCRIBE CP KIT WIRELESS, 41000-030-60; f) XSCRIBE CP KIT WIRED, 41000-030-62; g) XSCRIBE CP SW KIT, 41000-030-64
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 17, 2024
API JAMES 2AMP, CATALOG 70542
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
API NIT1 NIT2 REAGENTS, CATALOG 70442
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
API VP1 VP2 REAGENTS, CATALOG 70422
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
API 20 E 25 STRIPS, CATALOG 20100
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper
FDA Enforcement
Class II
·Ongoing·KCI USA, INC.·February 26, 2025
3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, US PRE4001AU PREVENA PLUS SYSTEM KIT, AU PRE4001CA PREVENA PLUS SYSTEM KIT, CA PRE4001UK PREVENA PLUS SYSTEM KIT, UK PRE4001US PREVENA PLUS SYSTEM KIT, US PRE4001 PREVENA PLUS SYSTEM KIT PRE4001ZA PREVENA PLUS SYSTEM KIT, ZA PRE4010 PREVENA PLUS STANDALONE EXTENDED LIFE SYSTEM KIT PRE5001 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 33X30 CM PRE5101 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 46X30 CM PRE5221 PREVENA RESTOR BELLA-FORM SYSTEM KIT 21X19 CM PRE5321 PREVENA RESTOR BELLA-FORM SYSTEM KIT 24X22 CM PRE5421 PREVENA RESTOR BELLA-FORM SYSTEM KIT 29X27 CM PRE5501 PREVENA RESTOR AXIO-FORM SYSTEM KIT 29X28 CM
FDA Enforcement
Class II
·Ongoing·KCI USA, INC.·February 26, 2025
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
FDA Enforcement
Class II
·Ongoing·KCI USA, INC.·December 4, 2024
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023