20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERTEX RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·January 12, 2012
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWQ·October 30, 2009
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 3, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code KWP·July 29, 2011
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 11, 2018
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 17, 2020
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 13, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·October 11, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 10, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·June 30, 2021
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 7, 2020
MEDEVIEW SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·April 2, 2013
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM (PACKAGED)
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·April 7, 2011
ENDOTAK RELIANCE G
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·June 29, 2018
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