General Purpose Probe

FDA registration

ICU Medical, Inc.·1 product·🇺🇸 United States

SANICURE BV

FDA registration

SANICURE BV·1 product·🇳🇱 Netherlands

General Purpose Probe

FDA registration

ICU Medical Healthcare Manufacturing S.A. de C.V.·1 product·🇲🇽 Mexico

Isomedix Operations Inc.

FDA registration

Isomedix Operations Inc.·1 product·🇺🇸 United States

ESOPHAGEAL RECTAL TEMPERATURE PROBE

FDA 510(k)

FDA Class 2 ·General Hospital

Terragene Bionova® IC10/20FR Reader Incubator

FDA registration

TERRAGENE SA·1 product·🇦🇷 Argentina

NIM

FDA registration

MEDTRONIC XOMED, INC.·1 product·🇺🇸 United States

NIM

FDA registration

Medtronic Engineering and Innovation Center (MEIC)·1 product·🇮🇳 India

Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-

FDA registration

TUTTNAUER LTD.·1 product·🇮🇱 Israel

ASP Global Manufacturing GmbH

FDA registration

ASP Global Manufacturing GmbH·1 product·🇨🇭 Switzerland

Sterilization Monitoring Products

FDA registration

O&M Halyard, Inc.·1 product·🇺🇸 United States

Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator

FDA 510(k)

FDA Class 2 ·General Hospital

OPTI

FDA 510(k)

FDA Class 1 ·Dental

Continuous Measurement Thermometer

FDA classification

FDA Class 2 ·Continuous Measurement Thermometer

Indicator, Biological Sterilization Process

FDA classification

FDA Class 2 ·Indicator, Biological Sterilization Process

Unit, Operative Dental

FDA classification

FDA Class 1 ·Unit, Operative Dental