12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEALEY REVISION COMPONENT SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123076·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 75mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471155992·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 230mm
ACCUMESH DEPLOYMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRULINE REINFORCED VALVED INFUSION CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code MBI·April 27, 2012
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022
DELTAPAQ - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MICRUS ENDOVASCULAR, LLC·Product code HCG·January 17, 2013
CAPSURE SP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 9, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015