17 results · 23ms · 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.

MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS

FDA 510(k)
FDA Class 2 ·Cardiovascular

KARMA DISCOVERY, MODEL KP40

FDA 510(k)
FDA Class 2 ·Physical Medicine

ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY

FDA 510(k)
FDA Class 2 ·Immunology

VERTE-STACK K030736, K041197

FDA Adverse Event
Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019

MOSAIC

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·March 12, 2019

CORNERSTONE-SR CAGE SYSTEM

FDA Adverse Event
Death ·MSD DEGGENDORF MFG·Product code ODP·February 17, 2012

HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·May 27, 2020

FLEXTEND

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·April 8, 2013

7900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEM GMBH·Product code JAA·March 23, 2011

H-TRONPLUS

FDA Adverse Event
Injury ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·May 8, 2008

MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021

CG COMPOSITE RING

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 2, 2020

DURAN ANCORE RING

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 2, 2020

MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 16, 2023

CG COMPOSITE RING

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·February 8, 2023

Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·December 12, 2012

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