9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
DIDECO COMPACTFLO EVOLUTION OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·January 15, 2016
HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE
FDA 510(k)
FDA Class 2
·Microbiology
ELCAM STOPCOCKS AND MANIFOLDS
FDA 510(k)
FDA Class 2
·General Hospital
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·May 3, 2013
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 16, 2014
ADVANTX LCA
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS·Product code IZI·April 11, 2011
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
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024