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

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NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON

FDA 510(k)
FDA Class 2 ·Anesthesiology

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756978774·SCLERA PROCESSING KIT

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK0100190·SNII Tap, 7.50mm

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)

STERILE SUBDERMAL NEEDLE ELECTRODES

FDA 510(k)
FDA Class 2 ·Neurology

RESPIRATORY HUMIDIFER

FDA 510(k)
FDA Class 2 ·Anesthesiology

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)

DIACAM (510(K) K 901019)

FDA Adverse Event
Other ·SIEMENS MEDICAL SYSTEMS·Product code KPS·March 13, 2001

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