20 results · 21ms · Sources: EU EUDAMED, US FDA

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Peel-Away Introducer Set

FDA 510(k)
FDA Class 2 ·Cardiovascular

2.0 x 130mm Drill Bit Calibrated

FDA UDI
Osteocentric Technologies, Inc.·00816950029516·2.0 x 130mm Drill Bit Calibrated

Paltop

FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108695649·Dynamic Dental Implant Ø3.25mm L13mm

LEONE SPA

FDA UDI
LEONE SPA·08033707018070·CALIBRA 1ST MOLAR BANDS n.LL 20

Ø3.5mm x 20mm Precontoured Cervical Rods

FDA UDI
XENCO MEDICAL LLC·B064XM21700201·

Ø3.5mm X 20mm PRECONTOURED CERVICAL RODS

FDA UDI
XENCO MEDICAL LLC·B064XMPH21700202·

DX SERIES FINGER SENSOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

COMCASET-P SAFETY IV CATHETER

FDA 510(k)
FDA Class 2 ·General Hospital

AMPLATZER SEPTAL OCCLUDER

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL·Product code MLV·March 25, 2022

AMPLATZER SEPTAL OCCLUDER

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL·Product code MLV·March 25, 2022

AMPLATZER SEPTAL OCCLUDER

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL·Product code MLV·May 7, 2022

Chart, X-Ref Ohio Med 617-0020-300, 5" x 200', 8L

FDA UDI
A-M SYSTEMS, LLC·00817081025644·Chart, X-Ref Ohio Med 617-0020-300, 5" x 200', 8L

GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code IYO·October 14, 2014

MESH-COMPOSIX

FDA Adverse Event
Injury ·DAVOL INC·Product code FTL·July 12, 2011

MEDTRONIC MINIMED PARADIGM523

FDA Adverse Event
Injury ·MEDTRONIC·Product code LZG·June 10, 2013

Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020

FDA Recall
Terminated ·Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel·Product code DZE·November 18, 2019

Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020

FDA Enforcement
Class II ·Terminated·Paltop Advanced Dental Solutions Ltd·January 29, 2020

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 4, 2026

MAGNETOM Skyra fit. Model Number: 10849580.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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