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

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Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)

FDA 510(k)
FDA Class 2 ·Radiology

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100226·THORLAKSON ASPIRATING SPECULUM

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100516·THORLAKSON EYE SPECULUM

ProLift

FDA UDI
Life Spine, Inc.·00190837106386·Static Expandable Cage Trial, 10mm x 28mm x 13m...

URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

XELERIS 2 PROCESSING AND REVIEW WORKSTATION

FDA 510(k)
FDA Class 2 ·Radiology

PENUMBRA SYSTEM MAX ASPIRATION TUBING

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·June 24, 2015

ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

G7 HI-WALL E1 LINER 36MM D

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PBI·October 30, 2024

ZB 12/14 COCR HD 36MM X +0

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·October 30, 2024

DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

FDA Adverse Event
Malfunction ·MPRI·Product code OJX·June 7, 2013

ALTRUA

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 6, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023