ADVANCED CIRCULATORY SYSTEMS INC 12-0707-000 ResQGARD FM Kit

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. 7 Disposable Sterilized Latex Surgical Gloves

Powder-free textured;The packages of proposed device including immediate package, middle box package and outer carton package.Immediate package quantity: 1 pairMiddle box package quantity: 50 pairsOuter carton package quantity: 400 pairs

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NOVA BIOMEDICAL CORPORATION 57400 Stat Profile Prime Plus Blood Gas Analyzer

The Stat Profile Prime Plus Blood Analyzer is a compact, whole blood critical care analyzer that provides rapid and comprehensive results. It measures blood gases, electrolytes, metabolites, and co-oximetry, delivering 32 calculated results. Featuring maintenance-free, replaceable cartridge technology and patented non-lysing co-oximetry, the analyzer produces a complete test panel in about one minute. It also offers bidirectional connectivity and a powerful onboard data management system for efficient data handling and integration

$7,381.36

Clinical Chemistry

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Flint Rehabilitation Devices LLC FM Flint Rehab

FitMi Exercise System

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MEDICAL DEVICE RESOURCE CORPORATION ITD MD Resource

ITD - Infiltration Disposable Tubing

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Kit

TOVA COMPANY, THE Kit T.O.V.A.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

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DELTA BRANDS INC. Kit Lucky Super Soft

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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Ulab Systems, Inc. 7 uLab Systems uDesign

The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.

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tyromotion GmbH 7 AMADEO

The AMADEO system is intended for robot-supported finger-hand therapy of patients with neurological damage to the central nervous system, caused by typical indications such as stroke or traumatic brain injury.

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BIOMAT USA, INC. 7 SGP (Plasma Management System)

SGP (acronym for Sistema de Gestion del Plasma or Plasma Management System) is an application designed to manage the logistics of plasma stored in a central warehouse of a plasma manufacturing organization or a fractionation facility. This includes all activities from receipt of plasma to fractionation, as it relates to storage and control of the plasma units.

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DOMICO MED-DEVICE, LLC 7

KIT, SMALL. Includes: 128 – WEDGE, 3” x 10” x 10” (00810050240819), 129 – WEDGE, 4.63" x 10" x 10" (00810050240314), 130 – WEDGE, 10" x 10" x 10" (00810050240826), 140 – WEDGE, 6" x 10" x 10" (00810050240369)

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Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. 7 Disposable Sterilized Latex Surgical Gloves

Powder-free textured;The packages of proposed device including immediate package, middle box package and outer carton package.Immediate package quantity: 1 pairMiddle box package quantity: 50 pairsOuter carton package quantity: 400 pairs

Out of Stock

General & Plastic Surgery

57400

NOVA BIOMEDICAL CORPORATION 57400 Stat Profile Prime Plus Blood Gas Analyzer

The Stat Profile Prime Plus Blood Analyzer is a compact, whole blood critical care analyzer that provides rapid and comprehensive results. It measures blood gases, electrolytes, metabolites, and co-oximetry, delivering 32 calculated results. Featuring maintenance-free, replaceable cartridge technology and patented non-lysing co-oximetry, the analyzer produces a complete test panel in about one minute. It also offers bidirectional connectivity and a powerful onboard data management system for efficient data handling and integration

$7,381.36

Clinical Chemistry

FM

Flint Rehabilitation Devices LLC FM Flint Rehab

FitMi Exercise System

Out of Stock

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ITD

MEDICAL DEVICE RESOURCE CORPORATION ITD MD Resource

ITD - Infiltration Disposable Tubing

Out of Stock

General & Plastic Surgery

Kit

TOVA COMPANY, THE Kit T.O.V.A.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

Out of Stock

Other

Kit

DELTA BRANDS INC. Kit Lucky Super Soft

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Out of Stock

General & Plastic Surgery

7

Ulab Systems, Inc. 7 uLab Systems uDesign

The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.

Out of Stock

Dental

7

tyromotion GmbH 7 AMADEO

The AMADEO system is intended for robot-supported finger-hand therapy of patients with neurological damage to the central nervous system, caused by typical indications such as stroke or traumatic brain injury.

Out of Stock

Physical Medicine

7

BIOMAT USA, INC. 7 SGP (Plasma Management System)

SGP (acronym for Sistema de Gestion del Plasma or Plasma Management System) is an application designed to manage the logistics of plasma stored in a central warehouse of a plasma manufacturing organization or a fractionation facility. This includes all activities from receipt of plasma to fractionation, as it relates to storage and control of the plasma units.

Out of Stock

Hematology

7

DOMICO MED-DEVICE, LLC 7

KIT, SMALL. Includes: 128 – WEDGE, 3” x 10” x 10” (00810050240819), 129 – WEDGE, 4.63" x 10" x 10" (00810050240314), 130 – WEDGE, 10" x 10" x 10" (00810050240826), 140 – WEDGE, 6" x 10" x 10" (00810050240369)

Out of Stock

Anesthesiology

7

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. 7 Disposable Sterilized Latex Surgical Gloves

Powder-free textured;The packages of proposed device including immediate package, middle box package and outer carton package.Immediate package quantity: 1 pairMiddle box package quantity: 50 pairsOuter carton package quantity: 400 pairs

Out of Stock

General & Plastic Surgery

ADVANCED CIRCULATORY SYSTEMS INC 12-0707-000 ResQGARD FM Kit

Description

Pricing
Summary

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ADVANCED CIRCULATORY SYSTEMS INC 12-0707-000 ResQGARD FM Kit

Description

Pricing Summary

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NOVA BIOMEDICAL CORPORATION 57400 Stat Profile Prime Plus Blood Gas Analyzer

Flint Rehabilitation Devices LLC FM Flint Rehab

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TOVA COMPANY, THE Kit T.O.V.A.

Additional Details

Categories

Barcode Mapping

Pricing
Summary