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

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ZIOCERA & CONVERTIBLE SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

VACUETTE SAFETY BLOOD COLLECTION SET

FDA 510(k)
FDA Class 2 ·General Hospital

TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG

FDA 510(k)
FDA Class 2 ·Dental

PVA FOAM EMBOLIZATION PARTICLES

FDA Adverse Event
Malfunction ·COOK INC·Product code KRD·March 26, 2018

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 9, 2011

HOMECHOICE CYCLER-REFURBISHED

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 18, 2008

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

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

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