9 results
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28ms
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Sources: EU EUDAMED, US FDA
TENSOPLUS LITE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PUR NP Cover Screw 5.0mm, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549107603·Component that is attached to implant to protec...
MAMMOSITE II RADIATION THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736
FDA 510(k)
FDA Class 2
·Orthopedic
AMS INTEXEN-PORCINE DERMIS
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS·Product code OTO·June 30, 2014
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP·Product code FPA·November 19, 2012
VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code MAF·November 17, 2010
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
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 10, 2019