44 results · 28ms · Sources: EU EUDAMED, US FDA

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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