15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)
FDA 510(k)
FDA Class 2
·Orthopedic
ALLON 2001 MODIFIED
FDA 510(k)
FDA Class 2
·Cardiovascular
ASTRONOMER PLUS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
POLYFLUX 17L
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER·Product code KDI·January 14, 2020
DUODOPA_DUOPA
FDA Adverse Event
Injury
·ABBVIE - MEDICAL DEVICE CENTER·Product code KNT·May 23, 2022
30 G SHORT PLASTIC
FDA Adverse Event
Injury
·Product code DZM·March 8, 2013
ON-Q PAINBUSTER SOAKER
FDA Adverse Event
Malfunction
·I-FLOW CORP.·Product code MEB·February 25, 2011
VITALITY 2 DR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 26, 2011
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 30, 2013
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·April 14, 2015
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·May 7, 2010
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·July 19, 2013
OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 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