12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACETAMINOPHEN-SL ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994325747·CONNECTOR 7042330 LAT CONN TI 5.5 32MM
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809872156·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND OPEN T...
NAVIGUS PEEL AWAY INTRODUCER
FDA 510(k)
FDA Class 2
·Neurology
SIMPLICITY EURO QD INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
PENUMA IMPLANT
FDA Adverse Event
Injury
·NATIONAL MEDICAL DEVICES INC.·Product code MIB·March 1, 2018
EON MINI
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 2, 2013
8800
FDA Adverse Event
Malfunction
·GE MED SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·February 15, 2011
VENTAK PRIZM 2 DR
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018