13 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITALAB DIRECT BILIRUBIN REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NEEDLE 18X1 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·September 16, 2024
NEEDLE 18X1 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·September 16, 2024
NEMIO
FDA 510(k)
FDA Class 2
·Radiology
IPLAN
FDA 510(k)
FDA Class 2
·Neurology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 8, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 22, 2011
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM
FDA Adverse Event
Malfunction
·BIOENTERICS CORPORATION·Product code LTI·May 7, 2008
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·January 19, 2025
IPC® HANDPIECE - POWEREASE¿ DRIVER
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code HBE·December 9, 2024
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024