11 results · 21ms · Sources: EU EUDAMED, US FDA

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SOLCART B

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

MILLENNIUM MICROSURGICAL SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ELECSYS DHEA-S CALSET

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VERCISE GEVIA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·April 27, 2021

SPIROFLEX® ANGIOJET® THROMBECTOMY SET

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

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 23, 2013

TARGET DEVICE 300X160MM

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·March 31, 2011

ATTAIN OTW

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWP·July 10, 2008

PRECISION SPECTRA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 8, 2024

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