11 results · 18ms · Sources: EU EUDAMED, US FDA

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OLYMPUS WORKING ELEMENT FOR PROBES

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PICCOLO BASIC METABOLIC PANEL

FDA Adverse Event
Malfunction ·ABAXIS, INC.·Product code CGX·October 22, 2020

PICCOLO COMPREHENSIVE METABOLIC PANEL

FDA Adverse Event
Malfunction ·ABAXIS, INC.·Product code CGX·November 3, 2020

VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH

FDA 510(k)
FDA Class 2 ·Dental

CONTINUOUS FLUSH DEVICE

FDA 510(k)
FDA Class 2 ·Cardiovascular

UNSPECIFIED SAFESET TRANSPAC SETS

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025

STELLANT

FDA Adverse Event
Malfunction ·MEDRAD, INC·Product code DXT·February 28, 2013

COLLEAGUE 3 TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP CE FRENC

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 15, 2011

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MPRI·Product code DTB·August 8, 2014

RUNWAY GUIDE CATHETER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022