16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942
FDA 510(k)
FDA Class 2
·Cardiovascular
Alice 6
FDA UDI
Respironics, Inc.·00606959020696·Alice 6 Base Station System LDE, International
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776316624·Pratt Rectal Speculum
MEDI MFG., INC.
FDA registration
MEDI MFG., INC.·17 products·🇺🇸 United States
P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)
FDA 510(k)
FDA Class 2
·Orthopedic
CONTROL PLASMA P
FDA 510(k)
FDA Class 2
·Hematology
LIBERTY CYCLER SET, SINGLE CONN/EXT DL
FDA Adverse Event
Malfunction
·REYNOSA MFG·Product code FKX·March 1, 2013
PUMP MMT-715NAS PRDGM INS V2.1 SK EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATONS MED-REL·Product code LZG·June 19, 2008
RESOLUTION HEMOSTASIS CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·April 19, 2011
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQX·August 30, 2023
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·December 23, 2022
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 19, 2025
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018