87 results · 22ms · Sources: EU EUDAMED, US FDA

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COLLAGEN RIBBON

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

LEONE SPA

FDA UDI
LEONE SPA·08033707008811·CALIBRA 1ST MOLAR BANDS n.UR 19

MIRABAY

FDA UDI
Mirabay Orthodontics Corp.·05061075023214·KLEOS 2 PSL METAL HIGH TORQUE 022 UR3 HK PK5

OptiMesh Multiplanar Expandable Interbody Fusion System

FDA UDI
SPINEOLOGY INC.·M7403120019·Stopped Pituitary Rongeur

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK1200110·Rod Gripper, 5.50mm Angled

POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

PASCAL STREAMLINE PHOTOCOAGULATOR

FDA 510(k)
FDA Class 2 ·Ophthalmic

KING SEPTEMS

FDA Adverse Event
Malfunction ·KING SEPTEMS·Product code LMA·November 1, 2012

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS EGFR MUTATION TEST

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

COBAS EGFR MUTATION TEST

FDA Adverse Event
ROCHE MOLECULAR SYSTEMS, INC.·Product code OWD·January 29, 2014