15 results · 31ms · Sources: EU EUDAMED, US FDA

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CHEETAH RELIANT

FDA 510(k)
FDA Class 2 ·Cardiovascular

LEONE SPA

FDA UDI
LEONE SPA·08033707065807·EXTRAORAL ELASTIC KIT

ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PALL ULTIPOR ANESTHESIA BREATHING SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

MILLENIA PTCA CATHETER

FDA Adverse Event
Malfunction ·MEDTRONICS INTERVENTIONAL VASCULAR·Product code LOX·June 4, 1997

MILLENIA PTCA CATHETER

FDA Adverse Event
Malfunction ·MEDTRONICS INTERVENTIONAL VASCULAR·Product code LOX·June 4, 1997

MILLENIA PTCA CATHETER

FDA Adverse Event
Malfunction ·MEDTRONIC INTERVENTIONAL VASCULAR·Product code LOX·April 7, 1997

MILLENIA PTCA CATHETER

FDA Adverse Event
Malfunction ·MEDTRONICS INTERVENTIONAL VASCULAR·Product code LOX·April 7, 1997

REBOUND HRD

FDA Adverse Event
Malfunction ·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011

X3 TRIATHLON CS INS SIZE4 11MM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·April 29, 2013

FOLEY CATH SIL-ELASTOMER 30FR

FDA Adverse Event
Other ·Product code KOD·April 28, 2011

SYNCHROMED EL

FDA Adverse Event
Malfunction ·RICE CREEK MANUFACTURING·Product code LKK·July 24, 2008

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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

Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

FDA Enforcement
Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022