3,620 results
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16ms
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Sources: EU EUDAMED, US FDA
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
FDA Enforcement
Class II
·Terminated·Surgical Specialties Mexico S DE RL DE CV·October 19, 2016
3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·August 15, 2012
VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·January 29, 2020
VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·April 22, 2020
Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·September 29, 2021
Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use.
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·July 11, 2012
4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·June 15, 2016
VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·February 27, 2013
VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical laboratory.
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·October 7, 2020
VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·May 12, 2021
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·October 6, 2021
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·January 26, 2022
40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Valve, Clamp, Rotating Luer.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018