11 results
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26ms
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Sources: EU EUDAMED, US FDA
QUIK-SEP IGM ISOLATION SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
Fresh Cells
FDA UDI
DIAGNOSTIC HYBRIDS, INC.·30014613333999·MDCK PLATES
NA
FDA UDI
LANCER ORTHODONTICS, INC.·00817573024162·MODULES-SAFETY 600g BLUE 10/PK
COULTER LH 750 BODY FLUIDS APPLICATION
FDA 510(k)
FDA Class 2
·Hematology
FMWAND FERROMAGNETIC SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MAESTRO SMALL STEERING DURAGUA
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBB·May 23, 2014
ENCORE BALLOON CATHETER INFLATION DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MAV·November 13, 2012
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·June 1, 2016
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023