15 results · 21ms · Sources: EU EUDAMED, 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