42 results
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51ms
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Sources: EU EUDAMED, US FDA
CLR MEDICAL, INC.
FDA registration
CLR MEDICAL, INC.·2 products·🇺🇸 United States
Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
FDA Enforcement
Class I
·Terminated·C.L.R. Medicals International, Inc.·January 1, 2014
Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
FDA Recall
Terminated
·C.L.R. Medicals International, Inc.·Product code LZP·November 25, 2013
COULTER EPICS XL-MCL 4 CLR FLOW CYTOMETRY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·October 21, 2011
ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs
FDA Recall
Open, Classified
·National Distribution & Contracting Inc·Product code ITX·August 24, 2021
I-STOP
FDA Adverse Event
Malfunction
·CL MEDICAL INC.·Product code FTL·December 11, 2012
I-STOPCL
FDA Adverse Event
Injury
·CL MEDICAL INC·Product code OTN·September 23, 2013
I-STOP TRANSVAGINAL MESH / SLING
FDA Adverse Event
Injury
·CL MEDICAL INC.·Product code OTN·January 9, 2020
I-STOP TRANSVAGINAL MESH
FDA Adverse Event
Injury
·CL MEDICAL INC. RIVERVIEW II·Product code FTL·October 26, 2012
AJW Technology Consulting GmbH
Authorized representative
🇩🇪 Germany·18 Manufacturers·23 Devices
Becton Dickinson Ireland Limited
Authorized representative
🇮🇪 Ireland·21 Manufacturers
BARD DAVOL
FDA Adverse Event
Injury
·C.R. BARD MEDICAL, INC.·Product code GCY·May 8, 1998
LUBRI-SIL I.C. COMPLETE CARE TEMPERATURE-SENSING
FDA Adverse Event
Malfunction
·BARD MEDICAL / C.R. BARD, INC.·Product code MJC·June 30, 2021
BARDEX I.C. COMPLETE CARE TEMPERATURE-SENSING INFECTION CONTROL FOLEY CATHETER
FDA Adverse Event
Malfunction
·BARD MEDICAL /C.R. BARD, INC.·Product code MJC·June 15, 2022
SURESTEP FOLEY TRAY SYSTEM
FDA Adverse Event
Malfunction
·BARD MEDICAL/ C.R. BARD INC.·Product code MJC·October 17, 2018
LUBRI-SIL I.C. COMPLETE CARE FOLEY CATHETER TRAY
FDA Adverse Event
Malfunction
·BARD MEDICAL / C.R. BARD, INC.·Product code EZL·July 1, 2021
FOLEY CATHETER INSERTION KIT
FDA Adverse Event
Malfunction
·BARD MEDICAL / C.R. BARD, INC.·Product code EZC·December 13, 2023
BARD MEDICAL SURESTEP FOLEY TRAY SYSTEM 16FR
FDA Adverse Event
Injury
·BARD MEDICAL /C.R. BARD, INC.·Product code MJC·July 25, 2022
DAVOL
FDA Adverse Event
Malfunction
·C.R. BARD, INC. MEDICAL DIV.·Product code FPD·November 6, 1997
Becton Dickinson Distribution Center N.V.
Importer
🇧🇪 Belgium·28 Manufacturers