9 results
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19ms
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Sources: EU EUDAMED, US FDA
SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
HHF1 ECHELON MULTI-PURPOSE COIL
FDA 510(k)
FDA Class 2
·Radiology
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·February 14, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·January 15, 2011
DIMENSION RXL MAX W/HM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·July 28, 2014
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 19, 2014
BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 6, 2016