8 results · 18ms · Sources: EU EUDAMED, US FDA

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HDL CHOLESTEROL PRECIPITATING REAGENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SeaSpine NewPort Spinal System

FDA 510(k)
FDA Class 2 ·Orthopedic

ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

PARADYM

FDA Adverse Event
Injury ·SORIN BIOMEDICA CRM S.R.L.·Product code NIK·October 22, 2010

RIATA ACTIVE FIXATION LEAD

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·January 13, 2014

ASR ACETABULAR CUPS 60

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·December 19, 2012

Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

FDA Enforcement
Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024