12 results · 21ms · Sources: EU EUDAMED, 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