11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SlimLine®
FDA UDI
ZIMMER SPINE, INC.·00889024404243·
MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOMEPUMP ECLIPSE: 400 ML, 100 ML/HR
FDA Adverse Event
Malfunction
·I-FLOW CORP.·Product code MEB·March 7, 2013
OXIMAX N-560 PULSE OXIMETER
FDA Adverse Event
Malfunction
·NELLCOR PURITAN BENNETT·Product code DQA·February 23, 2011
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·May 8, 2008
TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).
FDA Recall
Terminated
·Radiometer America Inc·Product code LKD·September 27, 2011
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
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