17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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