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

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TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS

FDA 510(k)
FDA Class 2 ·Cardiovascular

STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM

FDA Adverse Event
Death ·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013

BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732

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

SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301

FDA 510(k)
FDA Class 2 ·Cardiovascular

IMPLANTED PERIPHERALLY INSERTED CENTRAL CATHETER

FDA Adverse Event
Malfunction ·BARD ACCESS SYSTEMS·Product code LJS·May 6, 2014

DEXTRUS 4136

FDA Adverse Event
Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·January 2, 2013

OLYMPUS EVIS EXERA II COLONOVIDEOSCOPE

FDA Adverse Event
Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDS·November 11, 2010

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

The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

FDA Enforcement
Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019