12 results · 20ms · Sources: EU EUDAMED, US FDA

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DSS

FDA 510(k)
FDA Class 2 ·Orthopedic

RELION¿ INSULIN SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·November 27, 2017

DOUBLE SPRINGERS NONOXNOL 9 CONDOM

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8

FDA 510(k)
FDA Class 2 ·Neurology

SPIROFLEX® ANGIOJET® THROMBECTOMY SET

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DXE·August 17, 2016

UNKNOWN HIP ACETABULAR LINERS

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 14, 2021

UNKNOWN SUTURE PRODUCT

FDA Adverse Event
Injury ·ETHICON, INC SOMERVILLE·Product code GAM·April 23, 2013

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 22, 2011

CAPSUREFIX NOVUS

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

Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.

FDA Enforcement
Class II ·Terminated·Exactech, Inc.·October 7, 2020

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