25 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
FDA Recall
Terminated
·Flower Orthopedics Corporation·Product code HRS·September 3, 2021
UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm, Angiographic Catheter, Sterile, Merit Medical.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code DQO·November 5, 2003
Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.
FDA Recall
Terminated
·Ceg Enterprises Llc·Product code MCF·April 5, 2016
GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS MEDICAL LIMITED, FORTRAN ROAD, ST. MELLONS, CARDIFF, CF3 0LT, UK
FDA Recall
Terminated
·Gyrus Acmi, Incorporated·Product code GEI·August 6, 2010
Joerns Easy Care 2003 bed, Model B684; Joerns Easy Care 2003 DC bed, Model B684DC; Joerns Easy Care 2100, Model B694 AC-powered adjustable Hospital Beds
FDA Recall
Terminated
·Sunrise Medical CCG, Inc.·Product code FNL·November 16, 2005
Joerns Easy Care 2000, Model B784, Manual adjustable Hospital Bed
FDA Recall
Terminated
·Sunrise Medical CCG, Inc.·Product code FNJ·November 16, 2005
Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
FDA Recall
Terminated
·Sunrise Medical CCG, Inc.·Product code FNL·January 1, 2006
IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage: The DSL6600 IGFBP-3 immunoradiometric assay (IRMA) kit provides materials for the quantitative measurement of IGFBP-3 in serum. This assay is intended for in vitro diagnostic use.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CFL·August 9, 2010
VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112 VITROS LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CFJ·June 12, 2013
Advia Chemistry Assay: Lactate
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CFJ·March 17, 2016
Nichols Advantage Sample hGH Diluent Set (Catalog No. 62-7756)
FDA Recall
Terminated
·Nichols Institute Diagnostics·Product code CFL·May 2, 2005
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CFL·April 15, 2016
Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code CFJ·May 7, 2015
IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit. Part Numbers: 446360 (250 test kit) 446260 (50 test kit) 444970 (10 test kit)
FDA Recall
Terminated
·Beckman Coulter Inc·Product code CFF·January 28, 2004
Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF).
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CFJ·April 3, 2017
ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code CFL·March 5, 2018
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
FDA Recall
Terminated
·Helena Laboratories, Corp.·Product code CFF·July 21, 2017
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
FDA Recall
Terminated
·Medtest Holdings, Inc.·Product code CFJ·July 8, 2011
Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code CFJ·August 11, 2020
IGFBP-3 ELISA Reagent Kit; Part Number" DSL-10-6600; Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830 This assay is intended for in vitro diagnostic use.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CFL·March 30, 2011