20 results · 32ms · Sources: EU EUDAMED, US FDA

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STIFFER COAXIAL MICRO-INTRODUCER KIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600

FDA 510(k)
FDA Class 2 ·Immunology

UNIPLANT DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 31, 2023

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 4, 2023

COULTER LH 750 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·March 31, 2016

PROGRAMMING SOFTWARE

FDA Adverse Event
Malfunction ·CYBERONICS·Product code LYJ·April 22, 2013

PINN MAR +4 10D 36IDX54OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·April 15, 2011

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code NIQ·July 7, 2008

CAPIOX FX OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·May 22, 2025

CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·December 5, 2022

CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·December 16, 2022

CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·May 24, 2022

CAPIOX FX05 OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·May 19, 2023

CAPIOX FX25 OXYGENATOR

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 11, 2022

CAPIOX FX25 OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 11, 2022

CAPIOX FX25 OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 29, 2022

CAPIOX FX25 OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·February 14, 2022

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

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018