19 results · 48ms · Sources: EU EUDAMED, US FDA

ProFound AI V2.1

FDA registration
ICAD INC.·1 product·🇺🇸 United States

ProFound AI Software V2.1

FDA 510(k)
FDA Class 2 ·Radiology

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

FDA classification
FDA Class 2 ·Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Bernafon

FDA UDI
Bernafon AG·05711584086681·ZR3, KIT 312 2.4G NFM 85 R BE ZERENA 3

Apex Knee Modular Tibia System

FDA registration
OMNIlifeScience, Inc.·2 products·🇺🇸 United States

MOUNTAINEER Laminoplasty System

FDA registration
DEPUY SPINE, INC.·1 product·🇺🇸 United States

MOUNTAINEER Laminoplasty System

FDA registration
SYNTHES GMBH·1 product·🇨🇭 Switzerland

TOMZ Corporation

FDA registration
TOMZ Corporation·1 product·🇺🇸 United States

MOUNTAINEER Laminoplasty System

FDA registration
Synthes GMBH·1 product·🇨🇭 Switzerland

Modular Tibia Tray

FDA registration
MILLSTONE MEDICAL OUTSOURCING LLC.·2 products·🇺🇸 United States

Mountaineer OCT Spinal System

FDA registration
MEDOS INTERNATIONAL SARL·1 product·🇨🇭 Switzerland

Synergy Health Sterilisation UK Ltd

FDA registration
Synergy Health Sterilisation UK Ltd·2 products·🇬🇧 United Kingdom

Applied Medical Europe

FDA registration
Applied Medical Europe·1 product·🇳🇱 Netherlands

CLARUS Model 700

FDA registration
CARL ZEISS MEDITEC INC·1 product·🇺🇸 United States

TheraGenesis Non-Meshed Bilayer Wound Matrix

FDA registration
GUNZE LIMITED·1 product·🇯🇵 Japan

MOUNTAINEER LAMINOPLASTY SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

APEX KNEE MODULAR TIBIA SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Orthosis, Spine, Plate, Laminoplasty, Metal

FDA classification
FDA Class 2 ·Orthosis, Spine, Plate, Laminoplasty, Metal

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

FDA classification
FDA Class 2 ·Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer