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

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GNR TRAFFIC LIGHT PNA FISH

FDA 510(k)
FDA Class 1 ·Microbiology

Alpen Carbides

FDA UDI
Dent4You AG·07630392906050·Alpen Carbides 1558-FG-1.20-4.10, 10 pcs

MEDLINE INDUSTRIES, INC.

FDA UDI
MEDLINE INDUSTRIES, INC.·10198459391118·PLASTICS PACK

Needle Guide

FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436126257·Sterile TP Pivot Pro™ transperineal needle guid...

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)

FDA 510(k)
FDA Class 2 ·Microbiology

QUANTA DIODE LASER SYSTEM

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

QUANTA SYSTEM S.P.A.

FDA Adverse Event
Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2025

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013

S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) CONVEX MOLDABLE WAFER

FDA Adverse Event
Injury ·CONVATEC INC.·Product code EXE·August 19, 2014

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 20, 2011

MEDTRONIC TRANSCATHETER VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·October 6, 2021

COREVALVE TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 29, 2020

EVOLUT PRO TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 29, 2020

EVOLUT R TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 29, 2020

FREESTYLE AORTIC ROOT BIOPROSTHESIS

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·May 29, 2020

SOFT TISSUE BONE REDUCTION FORCEPS WITH BALL TIPS

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HTD·January 24, 2025

TherMax Blood Warmer Unit

FDA Enforcement
Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.

FDA Enforcement
Class II ·Terminated·ConvaTec, Inc·March 9, 2016

Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025