Electromagnetic Tracker

FDA registration

INTRICON CORPORATION·1 product·🇺🇸 United States

QUALITY TECH SERVICES, LLC

FDA registration

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

IG4 IMAGE GUIDED SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Olive Branch Distribution Center

FDA registration

Olive Branch Distribution Center·3 products·🇺🇸 United States

PALACOS® LV

FDA registration

Heraeus Medical GmbH·1 product·🇩🇪 Germany

PALACOS® LV

FDA registration

Heraeus Medical LLC·1 product·🇺🇸 United States

Highridge Medical, LLC

FDA registration

Highridge Medical, LLC·3 products·🇺🇸 United States

Sterigenics Germany GmbH

FDA registration

Sterigenics Germany GmbH·🇩🇪 Germany

MATIRA ANTERIOR CERVICAL SYSTEM

FDA UDI

Kalitec Direct LLC·B07307K0600030·Tray Insert, Level 3

Video Gastroscopes

FDA registration

Karl Storz Endoscopy-America, Inc.·3 products·🇺🇸 United States

Goldstein SonoBiopsy Catheter

FDA registration

Cook Incorporated·2 products·🇺🇸 United States

Goldstein SonoBiopsy Catheter

FDA registration

Cook Incorporated·2 products·🇺🇸 United States

ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TRI-FIX SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

System, X-Ray, Tomography, Computed

FDA classification

FDA Class 2 ·System, X-Ray, Tomography, Computed

Enzyme Immunoassay, Carbamazepine

FDA classification

FDA Class 2 ·Enzyme Immunoassay, Carbamazepine

Orthosis, Spinal Pedicle Fixation

FDA classification

FDA Class 2 ·Orthosis, Spinal Pedicle Fixation