612 results · 19ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR

FDA Recall
Open, Classified ·Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom·Product code GCJ·March 28, 2023

Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.

FDA Recall
Open, Classified ·Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom·Product code GCJ·January 20, 2022

YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR

FDA Recall
Open, Classified ·Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom·Product code GCJ·March 28, 2023

Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.

FDA Recall
Open, Classified ·Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom·Product code GCJ·January 20, 2022

The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.

FDA Recall
Open, Classified ·MAX LUX CORP 03e 01 01 Yangxi Indust Ry Zone Yangjiangyangjiang China·Product code RHP·October 26, 2021

Ldt, Unmet Need Within An Integrated Healthcare System

FDA classification
FDA Not Classified ·Ldt, Unmet Need Within An Integrated Healthcare System

Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test

FDA classification
FDA Class 1 ·Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

FDA classification
FDA Class 1 ·Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA classification
FDA Class 3 ·Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

FDA classification
FDA Not Classified ·Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

FDA classification
FDA Not Classified ·Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

FDA classification
FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule