1,136 results
·
7ms
·
Sources: EU EUDAMED, US FDA
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
Product 14 consists of all product under product code HSB , and same usage: Item no: 225600230 ASIA ONE-PIECE LAG SCREW 225600232 ASIA ONE-PIECE LAG SCREW 225600235 ASIA ONE-PIECE LAG SCREW 225600237 ASIA ONE-PIECE LAG SCREW 225600240 ASIA ONE-PIECE LAG SCREW 225600242 ASIA ONE-PIECE LAG SCREW 225600245 ASIA ONE-PIECE LAG SCREW 225600227 ASIA ONE-PIECE LAG SCREW 70MM Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
FDA Enforcement
Class II
·Terminated·Zimmer Manufacturing B.V.·March 23, 2016
Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.
FDA Enforcement
Class II
·Terminated·Medtest Holdings, Inc.·July 6, 2016
Product 55 consists of all product under product code: HSB and same usage: Item no: 225900132 ONE-PIECE LAG SCREW 11MM 225900135 ONE-PIECE LAG SCREW 11MM 225900137 ONE-PIECE LAG SCREW 11MM 225900140 ONE-PIECE LAG SCREW 11MM 225900142 ONE-PIECE LAG SCREW 11MM 225900145 ONE-PIECE LAG SCREW 11MM 225900152 ONE-PIECE LAG SCREW 11MM Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
FDA Enforcement
Class II
·Terminated·Zimmer Manufacturing B.V.·March 23, 2016
NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.
FDA Enforcement
Class II
·Terminated·NxStage Medical, Inc.·December 2, 2015
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
FDA Enforcement
Class II
·Terminated·NxStage Medical, Inc.·December 2, 2015
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
FDA Enforcement
Class II
·Terminated·NxStage Medical, Inc.·December 2, 2015
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
FDA Enforcement
Class II
·Terminated·NxStage Medical, Inc.·December 2, 2015
NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
FDA Enforcement
Class II
·Terminated·NxStage Medical, Inc.·December 2, 2015
COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile
FDA Enforcement
Class II
·Terminated·Epimed International·November 15, 2017