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

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MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120305891·Diamond, cone round, medium grit

MODEL 445SI-64E QUADRATURE WRIST COIL

FDA 510(k)
FDA Class 2 ·Radiology

VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT

FDA 510(k)
FDA Class 2 ·Neurology

ULTRACISION HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 2, 2013

7700

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 9, 2011

ASCENSIA CONTOUR

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·April 15, 2008

BD PHOENIX¿ PMIC-108

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 25, 2024

BD PHOENIX¿ PMIC-108

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 19, 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

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

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

OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012