17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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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