CATHETER ADAPTER SEALING CAP NO. 48-1028-9

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QM300 CALIBRATOR B PACK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PANASONIC BLOOD PRESSURE METER, ZH-852AP, ZH-858PP

FDA 510(k)

FDA Class 2 ·Cardiovascular

ERIKA ARTERIAL LINE 03-9625-9

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALLERCOAT MICROPLATE SYSTEM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ERIKA ARTERIAL LINE 03-9837-0

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POSTERIOR ANNULOPLASTY BAND (MODEL 607)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hiv Self-Tests

FDA classification

FDA Class 3 ·Hiv Self-Tests

Sanavita Pharmaceuticals GmbH

Manufacturer

🇩🇪 Germany·7 Basic UDI-DIs·7 Devices·TÜV SÜD Product Service GmbH, DQS Medizinprodukte GmbH, and DQS Medizinprodukte GmbH

Hiv-1 Genotyping Assay Using Ngs Technology

FDA classification

FDA Class 2 ·Hiv-1 Genotyping Assay Using Ngs Technology

Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

FDA classification

FDA Class 2 ·Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test

FDA classification

FDA Class 2 ·Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test

Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test

FDA classification

FDA Class 2 ·Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test

Nantong EgensBiotechnology Co.,Ltd.

Manufacturer

🇨🇳 China·35 Basic UDI-DIs·35 Devices·5 Importers·TÜV SÜD Product Service GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Labsystems Diagnostics Oy

Manufacturer

🇫🇮 Finland·74 Basic UDI-DIs·75 Devices·Eurofins Electric & Electronics Finland Oy, Eurofins Electric & Electronics Finland Oy, and Eurofins Electric & Electronics Finland Oy

Beckman Coulter Inc.

Manufacturer

🇺🇸 United States·975 Basic UDI-DIs·1166 Devices·17 Importers·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, and GMED SAS

Assay, Genotype, Hiv Drug Resistance, In Vitro

FDA classification

FDA Class 2 ·Assay, Genotype, Hiv Drug Resistance, In Vitro

BARRIER SURGICAL GOWNS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO TIELLE HYDROPOLMER DRESSING

FDA 510(k)

FDA Unclassified ·Unknown

KOMET SURGICAL BUR

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery