20 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MAGNETOM TRIO SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EXTERNAL DISTRACTION SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036010935·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033543269·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033543238·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033543283·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033543290·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033543252·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033543245·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033543276·
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 24, 2013
FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
PALAMED BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
REALIZE ADJ GASTRIC BAND-C
FDA Adverse Event
Injury
·OBTECH MEDICAL SARL_·Product code LTI·March 20, 2013
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·March 10, 2011
*
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JTC·February 29, 2008
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 6, 2015
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·March 27, 2024