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

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INTEGRE PRO, MODEL L2RY

FDA 510(k)
FDA Class 2 ·Ophthalmic

INFANT OXYGEN TREATMENT HOOD

FDA 510(k)
FDA Class 2 ·Anesthesiology

STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB

FDA 510(k)
FDA Class 2 ·Cardiovascular

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·April 29, 2013

TOTALCARE

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·April 13, 2011

ZYDERM 1 COLLAGEN IMPLANT (1.0ML)

FDA Adverse Event
Malfunction ·INAMED CORP (FREMONT)·Product code LMH·July 25, 2008

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 20, 2017

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 10, 2017

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·September 17, 2020

UNFOLDER PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·August 9, 2021

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·March 24, 2016

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·April 4, 2018

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 24, 2018

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 2, 2018

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·January 11, 2021

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

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