6 results · 6ms · Sources: EU EUDAMED, US FDA

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IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·September 28, 2016

cobas e801 Immunoassay Analyzer

FDA Enforcement
Class II ·Ongoing·Roche Diagnostics Operations, Inc.·August 17, 2022

DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)

FDA Enforcement
Class II ·Ongoing·ConvaTec, Inc·September 29, 2021

Drop Arm Versamode"

FDA Enforcement
Class II ·Terminated·Gf Health Products·April 14, 2021

Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912

FDA Enforcement
Class II ·Terminated·GF Health Products, Inc·December 21, 2016

Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.).

FDA Enforcement
Class II ·Terminated·GF Health Products, Inc./d.b.a.Basic American Metal Products·September 24, 2014