15 results · 22ms · Sources: EU EUDAMED, US FDA

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SONOSITE MAXX SERIES ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

PRECLUDE PERICARDIAL MEMBRANE

FDA 510(k)
FDA Class 2 ·Cardiovascular

SALUMEDICA NERVE CUFF

FDA 510(k)
FDA Class 2 ·Neurology

GRAFTYS HBS (510K NUMBER: K082498)

FDA Adverse Event
Injury ·GRAFTYS·Product code MQV·July 11, 2013

DEMEDIOX

FDA Adverse Event
Injury ·DEMETECH CORPORATION·Product code NEW·June 11, 2024

ACCU-CHEK SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·April 29, 2013

ADJUSTABLE PIN COLLET

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·April 26, 2011

SPACEMAKER BLUNT TIP TROCAR 10MM

FDA Adverse Event
Malfunction ·PONCE - USS·Product code GCJ·July 25, 2008

DEMEDIOX

FDA Adverse Event
Injury ·DEMETECH CORPORATION·Product code NEW·February 23, 2024

DEMEDIOX

FDA Adverse Event
Injury ·DEMETECH CORPORATION·Product code NEW·February 23, 2024

DEMEDIOX

FDA Adverse Event
Injury ·DEMETECH CORPORATION·Product code NEW·July 3, 2024

DEMEDIOX

FDA Adverse Event
Injury ·DEMETECH CORPORATION·Product code NEW·May 9, 2024

DEMEDIOX

FDA Adverse Event
Injury ·DEMETECH CORPORATION·Product code NEW·February 23, 2024

Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.

FDA Enforcement
Class II ·Terminated·Cook Inc.·August 31, 2016

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