9 results
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18ms
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Sources: EU EUDAMED, US FDA
TRAUMA SLEEVE
FDA 510(k)
FDA Class 1
·General Hospital
STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE
FDA 510(k)
FDA Class 2
·Cardiovascular
JETSTREAM G2 NXT SYSTEM, MODEL PV20300
FDA 510(k)
FDA Class 2
·Cardiovascular
PROMUS PREMIER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 30, 2014
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·November 9, 2010
XMAX MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code ERL·January 3, 2013
Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 6, 2016
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