7 results · 12ms · 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.

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO STERILE NAIL NIPPER FLD SPRG 4.5STER25, Model Number 96-2666A; 5) ECONO STERILE NAIL NIPPER 4 1/2" STERILE 50, Model Number 96-2667; 6) ECONO STERILE NAIL NIPPER BRL SPRG 5.5STER25, Model Number 96-2671A; nail procedures

FDA Enforcement
Class II ·Ongoing·Sklar Instruments·January 22, 2025

REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile

FDA Enforcement
Class II ·Ongoing·Orthofix Srl·June 25, 2025

Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S

FDA Enforcement
Class II ·Ongoing·EMPATICA SRL·November 1, 2023

Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system

FDA Enforcement
Class II ·Ongoing·NRT X-RAY A/S·May 15, 2024

1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)

FDA Enforcement
Class II ·Ongoing·NRT X-RAY A/S·February 2, 2022

Intelli-C, Left side suspended Tabletop, REF: 03400010

FDA Enforcement
Class II ·Ongoing·NRT X-RAY A/S·June 7, 2023

Intelli-C, Right side suspended Tabletop, REF: 03400000

FDA Enforcement
Class II ·Ongoing·NRT X-RAY A/S·June 7, 2023