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

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XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01

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

KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II

FDA 510(k)
FDA Class 2 ·General Hospital

DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE

FDA 510(k)
FDA Class 1 ·General Hospital

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 14, 2024

WAVEWRITER ALPHA? PRIME

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 20, 2026

VERTECEM V+ CEMENT KIT

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NDN·March 14, 2018

GAS MODULE III

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC·Product code BZK·April 30, 2013

PIN REV DOME DRILL 25MM

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LXH·September 16, 2014

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 5, 2011

BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·August 6, 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