44 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·LIFEPAK CR Plus defibrillator and LIFEPAK EXPRESS defibrillator
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·QUIK-PAK Electrodes
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and LIFEPAK 1000® defibrillator
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·QUIK-PAK Electrodes
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·QUIK-PAK Electrodes
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Infant/Child Reduced Energy Defibrillation Electrodes
LIFEPAK CR(R) PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·December 10, 2018
DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169502475·PLATE 2160012 ALIF PLATE 12MM
Humeris Shoulder
FDA UDI
FX SOLUTIONS·03701037301579·HUMERIS STEM TA6V SIZE 12 CEMENTLESS Ti/HA
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776166762·Hohmann Retractor long blade degree
LEONE SPA
FDA UDI
LEONE SPA·08033707016885·CALIBRA 1ST MOLAR BANDS n.LR 12
Alira Medical Devices
FDA UDI
Alira Medical Devices, LLC·G767S1600120·Caplan Nasal Septum Scissors - Serrated | 21cm ...
21m Cervical Plate with Cover Plate for 12mm Interbody
FDA UDI
XENCO MEDICAL LLC·B064XM21600121·
21mm CERVICAL PLATE FOR 12mm INTERBODY
FDA UDI
XENCO MEDICAL LLC·B064XM31600121·
21mm CERVICAL PLATE FOR 12mm INTERBODY
FDA UDI
XENCO MEDICAL LLC·B064XMPH31600121·
O-pel Laser and families of probe delivery devices
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·NUVASIVE PCM CERVICAL DISC SYSTEM
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·NUVASIVE PCM CERVICAL DISC SYSTEM