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

bcr/abl1 Monitoring Test

FDA registration
VWR CHEMICALS, LLC·2 products·🇺🇸 United States

Xpert BCR-ABL Ultra

FDA registration
Cepheid·2 products·🇺🇸 United States

Xpert BCR-ABL Ultra

FDA registration
CEPHEID·2 products·🇺🇸 United States

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)
FDA Class 2 ·Medical Genetics

Bcr/Abl1 Monitoring Test

FDA classification
FDA Class 2 ·Bcr/Abl1 Monitoring Test

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690196396·AK3 Femoral Instruments Pan

Reprocessed Ultrasound Catheter

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

Isomedix Operations, Inc.

FDA registration
Isomedix Operations, Inc.·1 product·🇺🇸 United States

QUALITY TECH SERVICES, LLC

FDA registration
QUALITY TECH SERVICES, LLC·1 product·🇺🇸 United States

Salto Talaris Total Ankle Prosthesis

FDA registration
Ascension Orthopedics, Inc.·1 product·🇺🇸 United States

Ultrasound Catheter

FDA registration
Nypro Inc (Maple Grove)·1 product·🇺🇸 United States

MILLSTONE MEDICAL OUTSOURCING LLC.

FDA registration
MILLSTONE MEDICAL OUTSOURCING LLC.·1 product·🇺🇸 United States

Isomedix Operations, Inc.

FDA registration
Isomedix Operations, Inc.·1 product·🇺🇸 United States

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690195108·AK3 Femoral Instruments Pan Insert

StrykerIreland (TL) - 12cm iQ Serrated Large

FDA registration
Synergy Health Ireland Ltd·1 product·🇮🇪 Ireland

TURNER MEDICAL INC.

FDA registration
TURNER MEDICAL INC.·1 product·🇺🇸 United States

SALTO TALARIS TOTAL ANKLE PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

ATRIUM C-QUR OVT MESH

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

XK-05636

FDA registration
OMNIlifeScience, Inc.·1 product·🇺🇸 United States

Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

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