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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

NAVIGATOR APPLICATIONS SUITE

FDA 510(k)
FDA Class 2 ·Anesthesiology

KIMAX REMOTE VIEWING STATION

FDA 510(k)
FDA Class 2 ·Radiology

ACCESS ULTRASENSITIVE HGH CALIBRATORS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

WIKTOR PRIME STENT DELIVERY SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC INTERVENTIONAL VASCULAR·Product code MAF·May 6, 1998

WIKTOR PRIME DELIVERY SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC INTERVENTIONAL VASCULAR·Product code MAF·May 6, 1998

WAVEWRITER ALPHA? PRIME

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 28, 2026

DEXTRUS 4137

FDA Adverse Event
Injury ·BIOTRONIK SE & CO. KG·Product code NVN·April 29, 2013

DUROM ACETABULAR COMPONENT

FDA Adverse Event
Other ·ZIMMER GMBH·Product code KWA·April 28, 2011

KINETRA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·July 24, 2008

MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·October 23, 2013

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