25 results
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19ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8
FDA Recall
Terminated
·Toray Marketing & Sales (America), Inc·Product code FJI·December 30, 2003
Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU
FDA Recall
Terminated
·Toray Marketing & Sales (America), Inc·Product code FJI·December 30, 2003
Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene block polymer, sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model AM-NR-65U - 1.3 m2 surface area, Model AM-NR-75U - 1.5 m2 surface area and Model AM-NR-100U - 2.0 m2 surface area
FDA Recall
Terminated
·Asahi Medical Co., Ltd·Product code FJI·October 12, 2006
Hollow Fiber Dialyzer Model FILTRYZER B3-1.0A, B3 -1.3A, and B3-1.6a
FDA Recall
Terminated
·Toray Marketing & Sales (America), Inc·Product code FJI·December 30, 2003
Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code FJI·February 26, 2016
Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H
FDA Recall
Terminated
·Toray Marketing & Sales (America), Inc·Product code FJI·December 30, 2003
Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Bladder. The instrument is introduced via the urethra when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 6, 2016
Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part number(s): A48617 The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CDZ·July 26, 2010
Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 25, 2012
Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 25, 2012
Air bubble detect module, catalog 802110, Terumo Cardiovascular System Corp, Ann Arbor, MI. The air bubble detect module is used with an air sensor to detect gross air bubbles in the perfusion circuit.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·December 2, 2010
Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 21, 2012
Occluder module, catalog 803480, Terumo Cardiovascular System Corp, Ann Arbor, MI. The occluder module is used with the Occluder head to provide a computer controlled tube clamping mechanism to regulate the flow in the venous line.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·December 2, 2010
Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 21, 2012
FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for use in a variety of austere environments.
FDA Recall
Terminated
·Fort Defiance Industries, LLC·Product code FLE·May 24, 2018
FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for use in a variety of austere environments.
FDA Enforcement
Class II
·Terminated·Fort Defiance Industries, LLC·July 18, 2018
Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.
FDA Recall
Terminated
·SEPPIM SAS ZONE INDUSTRIELLE SEES France·Product code CJY·September 4, 2013
VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack Product Usage: For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms).
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CJY·May 18, 2016
Consult Diagnostics Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum
FDA Recall
Terminated
·Vital Diagnostics, Inc.·Product code CJY·August 29, 2013
Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code CJY·December 4, 2018