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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Selenia Dimensions 3D System - 15420045500013

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Hologic, Inc.
3D software
In Commercial Distribution

  • 15420045500013 ()
SW-01648

  • Stationary mammographic x-ray system, digital

3Dimensions - 15420045510593

Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
3DM-SYS-INTL2D-MOB
In Commercial Distribution

  • 15420045510593 ()
3DM-SYS-INTL2D-MOB

  • Stationary mammographic x-ray system, digital

3Dimensions - 15420045510562

Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
3DM-SYS-INTL3D-MOB
In Commercial Distribution

  • 15420045510562 ()
3DM-SYS-INTL3D-MOB

  • Stationary mammographic x-ray system, digital

3Dimensions - 15420045508033

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Hologic, Inc.
ASY-10636-3D
In Commercial Distribution

  • 15420045508033 ()
ASY-10636-3D

  • Stationary mammographic x-ray system, digital

3Dimensions - 15420045507296

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Hologic, Inc.
3DIMENSIONS SOFTWARE
In Commercial Distribution

  • 15420045507296 ()
SW-04883

  • Stationary mammographic x-ray system, digital

Minerva Single Sterile Disposable Handpiece - 00862393000162

STERILE MINERVA Disposable Handpiece Contents: (1) One Single use STERILE Minerva ES Disposable Handpiece (1) One Single Use STERILE Syringe (1) One Single Use STERILE 8mm Hegar Dilator (1) One Single use NON-STERILE Desiccant (1) One NON-STERILE Handpiece Instructions For Use (1) One NON-STERILE Dilator Instructions For Use
Minerva Surgical, Inc.
MIN9770
In Commercial Distribution

  • 00862393000162 ()
  • 00862393000117 ()
MIN9770

  • Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument

EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL (5) NON-CE - 07290019402305

ExAblate 4000 (Neuro) EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL (5) NON-CE The membrane and DQA are for 5 treatment reuse
INSIGHTEC LTD
SET001043 EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL (5) NON-CE
In Commercial Distribution

  • 07290019402305 ()
SET001043

  • Therapeutic oncological/gynaecological ultrasound system

AMS 700 CXR RTE Kit - 00878953002408

Rear Tip Extenders for AMS 700 CXR Cylinders, 2 each of Non-Stackable 0.5, 1, 2, 3 cm RTEs and Stackable 1.5 cm RTEs
BOSTON SCIENTIFIC CORPORATION
72403872
In Commercial Distribution

  • 00878953002408 ()

  • Length: 3 Centimeter
  • Length: 2 Centimeter
  • Length: 1.5 Centimeter
  • Length: 1 Centimeter
  • Length: 0.5 Centimeter
72403872

  • Inflatable penile prosthesis

HEMOBLAST Bellows Laparoscopic Applicator - 03760193182668

HEMOBLAST Bellows Laparoscopic Applicator is intended for delivery of HEMOBLAST Bellows hemostatic powder to bleeding surgical sites through a 5mm or larger trocar.
DILON TECHNOLOGIES FRANCE
LAP01-US
In Commercial Distribution

  • 03760193182668 ()
  • 23760193182662 ()
  • 13760193182665 ()
LAP01-US

  • Collagen haemostatic agent, non-antimicrobial

therascreen® PIK3CA RGQ PCR Kit - 04053228034223

The therascreen PIK3CA RGQ PCR Kit is a real-time qualitative PCR test for the detection of 11 mutations in the phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) gene (Exon 7: C420R; Exon 9: E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and Exon 20: H1047L, H1047R, H1047Y) using genomic DNA (gDNA) extracted from formalin-fixed, paraffin-embedded (FFPE) breast tumor tissue or circulating tumor DNA (ctDNA) from plasma derived from K2EDTA anticoagulated peripheral whole blood taken from patients with breast cancer. The test is intended to aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY® (alpelisib) based on a PIK3CA Mutation Detected result. Patients whose FFPE tissue or plasma specimen produces a positive therascreen PIK3CA RGQ PCR Kit test result for the presence of one or more PIK3CA mutations are eligible for treatment with PIQRAY (alpelisib). Patients whose plasma specimen produces a negative result using this test should be reflexed to testing with FFPE tumor tissue for the presence of PIK3CA mutations. FFPE tumor specimens are processed using the QIAamp DSP DNA FFPE Tissue Kit for manual sample preparation. K2EDTA anticoagulated whole peripheral venous blood plasma specimens are processed using the QIAamp DSP Circulating Nucleic Acid Kit for manual sample preparation. For both specimen types, the Rotor-Gene Q (RGQ) MDx (US) instrument is used for automated amplification and detection. The Kit is to be used by trained personnel in a professional laboratory environment.
QIAGEN GmbH
V1
In Commercial Distribution

  • 04053228034223 ()
873121

  • PIK3CA gene mutation IVD, kit, nucleic acid technique (NAT)
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