20 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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