27 results · 22ms · Sources: EU EUDAMED, US FDA

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iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System

FDA 510(k)
FDA Class 2 ·Orthopedic

Inspire™ Esthetic Provisional Composite B1

FDA UDI
DEN-MAT HOLDINGS, LLC·00359883003982·Esthetic Provisional Composite

Inspire™ Esthetic Provisional Composite B1

FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172010535·Esthetic Provisional Composite

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704284676·

APEX Revision Knee

FDA UDI
Omni Life Science, Inc.·00841690124580·Modular Offset Stem 17mm x 100mm x 4mm

ECG

FDA UDI
Zoll Medical Corporation·00847946021849·12 LEAD ECG LIMB LEAD, 7FT BLACK

EASY CUFF

FDA 510(k)
FDA Class 2 ·Anesthesiology

MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE

FDA 510(k)
FDA Class 2 ·Radiology

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020

RADIFOCUS GLIDEWIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018

IMPAX CV REPORTING

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 7, 2013

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011

HARMONIC ACE 36 CM

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·September 10, 2008

CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·September 3, 2024

CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code NKB·July 28, 2025

CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code NKB·July 28, 2025

CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·April 2, 2025

CD HORIZON® SOLERA® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., HU·Product code NKB·March 20, 2026

CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code MNI·December 9, 2025

CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·April 16, 2024