14 results · 47ms · Sources: EU EUDAMED, US FDA

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FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Genius Total Knee System

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215022594·

Crescendo Meniscal Insert CR Standard 11mm Size 4

FDA UDI
AMPLITUDE SAS·03701089524278·

K.E.A.T.

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE

FDA 510(k)
FDA Class 2 ·Radiology

AISYS

FDA Adverse Event
Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 18, 2016

WAVEWRITER ALPHA PRIME 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 23, 2025

AISYS

FDA Adverse Event
Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016

HEPARIN

FDA Adverse Event
Injury ·TYCO HEALTHCARE (NOW COVIDIEN)·Product code NZW·June 2, 2008

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013

COLLEAGUE PUMP CE ENGLISH VERSION

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 28, 2011

SPRINT

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

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 MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018