11 results
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19ms
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Sources: EU EUDAMED, US FDA
AUTOMATED BLOOD CELL SEPARATOR
FDA 510(k)
FDA Unclassified
·Unknown
LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MALDI BIOTYPER CA (MBT-CA) SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
ACHIEVE MAPPING CATHETER
FDA Adverse Event
Injury
·MEDTRONIC ABLATION FRONTIERS·Product code DRF·August 15, 2013
19MM SHALLOW MILLED BODY COMPONENT 9002-0-5501
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LZO·May 23, 2014
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·November 13, 2012
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2015
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
FDA Enforcement
Class II
·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·August 14, 2024
SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024
The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.
FDA Enforcement
Class II
·Terminated·Hospira Inc.·July 20, 2016