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510(k) Data Aggregation
K Number
K162829Device Name
Medline UNITE® Ankle Fracture Plating System
Manufacturer
MEDLINE, INDUSTRIES, INC.
Date Cleared
2016-12-09
(63 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
MEDLINE, INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medline UNITE® Ankle Fracture Plates and Screws are intended for fixation of fractures, and nonunions of the distal tibia and fibula such as:
- · Lateral Malleolar Fractures
- · Syndesmosis Injuries
- · Medial Malleolar Fractures
- Bi-Malleolar Fractures
- · Tri-Malleolar Fractures
- Posterior Malleolar Fractures
- Distal Anterior Tibia Fractures
- · Vertical Shear Fractures of the Medial Malleolous
- · Pilon Fractures
- Distal Tibia Shaft Fractures
- Distal Fibula Shaft Fractures
- · Distal Tibia Periarticular Fractures
- · Medial Malleolar Avulsion Fractures
- · Lateral Malleolar Avulsion Fractures
The Medline Locking and Non-Locking Cortical and Cancellous Screws are indicated for use with the Medline Ankle Fracture Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the device.
Device Description
Medline UNITE® Ankle Fracture Plating System are manufactured from Titanium Alloy. The system includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, and 2.7mm and 3.5mm diameter locking cortical screws, 4.0mm Cancellous Screws, 4.0mm Medial Hook plate screws and 4.0mm Headed Cannulated screws to be used with the polyaxial locking holes and compression slots included in the plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drill guides, tissue protectors, and drill bits.
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K Number
K161473Device Name
Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
Manufacturer
MEDLINE, INDUSTRIES, INC.
Date Cleared
2016-10-19
(145 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MEDLINE, INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
The Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs) are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free and are made of nitrile with a blue colorant. The gloves are offered non-sterile and are available in small, medium, large and extra-large sizes.
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. The subject device was tested according to ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times were determined for a wide range of chemotherapy agents.
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K Number
K120008Device Name
MEDLINE HIGH PRESSURE INJECTION TUBING
Manufacturer
MEDLINE, INDUSTRIES, INC.
Date Cleared
2012-08-17
(227 days)
Product Code
DQO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
MEDLINE, INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline High Pressure Tubing is indicated for use during coronary angiography procedures as a connecting line for the injection of radiopaque dye or saline.
Device Description
Not Found
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K Number
K112769Device Name
CURAD COMPRESSION HOSIERY
Manufacturer
MEDLINE, INDUSTRIES, INC.
Date Cleared
2012-03-01
(160 days)
Product Code
DWL
Regulation Number
880.5780Why did this record match?
Applicant Name (Manufacturer) :
MEDLINE, INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Curad Compression Hosiery is intended for use in helping prevent edema and leg discomfort, and helping prevent deep vein thrombosis (DVT) in individuals subjected to immobility.
15-20mmHg: Helps to prevent edema and leg discomfort, and helps to prevent deep vein thrombosis (DVT) in individuals subjected to immobility. Especially for long distance travelers and those on their feet for extended periods of time.
20-30mmHg: Helps to prevent the pooling of blood in the legs and apply controlled pressure to the legs.
30-40mmHg: Helps to prevent edema and leg discomfort and helps to prevent deep vein thrombosis.
Device Description
Not Found
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K Number
K111955Device Name
MEDLINE PNEUMOPERITONEUM NEEDLE
Manufacturer
MEDLINE, INDUSTRIES, INC.
Date Cleared
2011-11-16
(128 days)
Product Code
HIF, FHO
Regulation Number
884.1730Why did this record match?
Applicant Name (Manufacturer) :
MEDLINE, INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline Pneumoperitoneum Needle has applications in gynecologic and abdominal endoscopic procedures for establishment of a pneumoperitoneum.
Device Description
Not Found
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K Number
K111147Device Name
MEDLINE VESSEL CANNULA
Manufacturer
MEDLINE, INDUSTRIES, INC.
Date Cleared
2011-07-19
(85 days)
Product Code
DWF
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
MEDLINE, INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medline Vessel Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery or in vascular surgery to perfuse a vein graft or to help check for leaks in a harvested vein which will be used for a graft.
Device Description
Medline's Vessel Cannula are to be supplied as sterile, non-pyrogenic, single use, disposable devices. They are visually transparent and consist of a flexible, kink resistant body with a one way valve. This vessel cannula is 2 inches in length and terminates with a female luer and a soft blunt tip.
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K Number
K110194Device Name
MEDLINE EPIDURAL AND SPINAL NEEDLES
Manufacturer
MEDLINE, INDUSTRIES, INC.
Date Cleared
2011-06-17
(144 days)
Product Code
BSP
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
MEDLINE, INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.
Device Description
Not Found
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