8 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-MHW and ASK-42703-OLL1
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 6, 2018
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
FDA Enforcement
Class II
·Ongoing·Zoe Medical Incorporated·September 18, 2024
Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·October 30, 2024
Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·October 30, 2024
Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·October 30, 2024
Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·October 30, 2024
remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).
FDA Enforcement
Class II
·Terminated·Thermo Fisher·June 20, 2018
MIM software; System, Image Processing, Radiological
FDA Enforcement
Class II
·Ongoing·MIM Software Inc·March 12, 2025