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

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ELI 380 ELECTROCARDIOGRAPH

FDA 510(k)
FDA Class 2 ·Cardiovascular

Preat

FDA UDI
Preat Corporation·00842092138908·Equator Abutment for MegaGen AnyRidge x 6mm

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690192916·10mm X 150mm Stem Pilot

LACTOSORB* 2.0MM SYSTEM TEMPLATE

FDA UDI
BIOMET MICROFIXATION, INC·00841036092672·

SMI CARDIOVASCULAR PATCH

FDA 510(k)
FDA Class 2 ·Cardiovascular

CLIPPER DIAGNOSTIC ELECTRODE CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

FDA Adverse Event
Injury ·COOK INC·Product code DTK·July 6, 2017

GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

FDA Adverse Event
Injury ·COOK INC·Product code DTK·July 6, 2017

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 4, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011

UNKNOWN

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DTK·October 23, 2017

UNKNOWN

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DTK·October 23, 2017

GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DTK·October 20, 2017

GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05

FDA Recall
Terminated ·GE Medical Systems Information Technologies·Product code LLZ·July 18, 2005

Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026