4,426 results · 49ms · Sources: EU EUDAMED, US FDA

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DEFLUX INJECTABLE GEL

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Oncomine Dx Target

TrueDent-D

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Stratasys Ltd.·5 devices

Power Tilts

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Stealth Products, LLC.·1 device

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Pamira S DX 65/15, Pamira S DX 65/17, Plexa ProMRI S DX 65/15, Plexa ProMRI S DX 65/17

DD Prefab DFX 38 Set

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Dental Direkt GmbH·1 device

DD Prefab DFX 55 Set

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Dental Direkt GmbH·1 device

DD Prefab DFX 45 Set

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Dental Direkt GmbH·1 device

PRO-DEX Battery Pack, Single

Basic UDI-DI
EU MDD · Eu Md Class 1 ·Pro-Dex, Inc.·1 device

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Oncomine Dx Target Test

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VARIOUS MODELS OF IPG'S: ACTROS, AXIOS, CYLOS, DROMOS, KAIROS, PHILOS/II, PROTOS, ETC.

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·STRATOS LV/LV-T, EVIA AND ENTOVIS HF/HF-T CRT-P'S

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·ILESTO 7/ 5 VR-T ICD, IFORIA 7/ 5 VR-T ICD, ILESTO 7/ 5 VR-T DX ICD, ILFORIA 7/ 5 VR-T DX ICD, ILESTO 7/ 5 DR-T ICD

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·BELOS & LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Oncomine Dx Target Test

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Oncomine Dx Target Test

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·LINOX S DX

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·AV PLUS DX

Diode Laser Therapy System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Intensity Pulsed Light Therapy System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery