70 results · 23ms · Sources: EU EUDAMED, US FDA

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U80 Series Upper Arm Electronic Blood Pressure Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

OsteoMed

FDA UDI
OSTEOMED LLC·00845694035637·Cannulated Tap for 6.5 Screws

Humeris Shoulder

FDA UDI
FX SOLUTIONS·03701037304594·HUMERIS STEM TA6V SIZE 19 CEMENTLESS Ti/HA

LEONE SPA

FDA UDI
LEONE SPA·08033707016953·CALIBRA 1ST MOLAR BANDS n.LR 19

PASCAL STREAMLINE PHOTOCOAGULATOR

FDA 510(k)
FDA Class 2 ·Ophthalmic

ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 7, 2025

MR850

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 11, 2026

FISHER AND PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE·Product code BTT·September 22, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 6, 2024

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 10, 2024

FISHER AND PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE·Product code BTT·November 4, 2025

FISHER AND PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE·Product code BTT·November 19, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 10, 2024

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Injury ·Product code BTT·February 18, 2021

MR850

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE·Product code BTT·March 26, 2026

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·Elecsys HBsAg II

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·Elecsys HBsAg II

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·Elecsys HBsAg II, PreciControl HBsAg II, Elecsys HBsAg Confirmatory Test, Elecsys HBsAg II Auto Confirm, PreciControl HB