19 results · 23ms · Sources: EU EUDAMED, US FDA

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DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BILOX PROSTHESIS HEAD 12/14 28MM L

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·May 23, 2014

KENDRO HERACELL 240 INCUBATOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT

FDA 510(k)
FDA Class 2 ·Hematology

REBOUND HRD

FDA Adverse Event
Malfunction ·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011

BIOLOX PROSTHESIS HEAD 12/14 28MM S

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012

BIOLOX PROSTHESIS HEAD 12/14 28MM S

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 14, 2014

BIOLOX PROSTHESIS HEAD 12/14 28MM M

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012

BIOLOX PROSTHESIS HEAD 12/14 32MM L

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014

BIOLOX PROSTHESIS HEAD 12/14 28MM S

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014

FEMORAL CANNULA

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DWF·April 29, 2013

MAXCEM ELITE

FDA Adverse Event
Injury ·KERR CORPORATION·Product code EMA·May 10, 2011

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Death ·CORDIS DE MEXICO·Product code NIQ·July 23, 2008

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 11, 2019

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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