18 results · 25ms · Sources: EU EUDAMED, US FDA

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INQU

FDA 510(k)
FDA Class 2 ·Orthopedic

COLOSCREEN-ES

FDA 510(k)
FDA Class 2 ·Hematology

LP(A)-LATEX SEIKEN ASSAY KIT

FDA 510(k)
FDA Class 2 ·Immunology

ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

FDA Adverse Event
Malfunction ·COOK, INC.·Product code MIH·March 28, 2013

POWER PRO AMBULANCE COT

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code INK·April 11, 2011

CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·June 19, 2008

ALINITY I HAVAB IGM REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LOL·March 26, 2026

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 26, 2011

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 30, 2013

FLEXCATH ADVANCE STEERABLE SHEATH

FDA Adverse Event
Injury ·MEDTRONIC CRYOCATH LP·Product code DRA·January 11, 2023

FLEXCATH ADVANCE STEERABLE SHEATH

FDA Adverse Event
Injury ·MEDTRONIC CRYOCATH LP·Product code DRA·August 2, 2023

ACHIEVE MAPPING CATHETER - 20 MM

FDA Adverse Event
Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code DRF·August 2, 2023

ACHIEVE MAPPING CATHETER - 20 MM

FDA Adverse Event
Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code DRF·January 11, 2023

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·April 14, 2015

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·May 7, 2010

CORMATRIX ECM FOR PERICARDIAL CLOSURE

FDA Adverse Event
Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·July 19, 2013

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015