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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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CATHETER AFR-00001 SPHERE 9 1PK US
MEDTRONIC, INC.
AFR-00001
In Commercial Distribution

  • 00763000871741 ()

  • Catheter diameter 2.7 mm (8F)
  • Catheter shaft length 115 cm
  • Expandable ablation electrode diameter 9.3 mm


  • Cardiac radio-frequency ablation system catheter
The XVIVO Organ Chamber™ is intended to be used as a temporary receptacle for isolated donor lungs in preparation for eventual transplantation into a recipient.
Xvivo Perfusion AB
19020
In Commercial Distribution

  • 07350069520074 ()
19020

  • Lung donor-organ preservation/evaluation system lung-interface set
The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement. The implant is indicated as an internal support in the treatment of flat foot, providing structural support.
Ascension Orthopedics, Inc.
40012
Not in Commercial Distribution

  • M2480400120 ()
  • 10381780066590 ()

  • 12 mm dia x 15 mm L
40012

  • Subtalar implant, non-bioabsorbable
The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement. The implant is indicated as an internal support in the treatment of flat foot, providing structural support.
Ascension Orthopedics, Inc.
040011
Not in Commercial Distribution

  • M2480400110 ()
  • 10381780066583 ()

  • 11 mm dia x 15 mm L
040011

  • Subtalar implant, non-bioabsorbable
The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement. The implant is indicated as an internal support in the treatment of flat foot, providing structural support.
Ascension Orthopedics, Inc.
040010
In Commercial Distribution

  • M2480400100 ()
  • 10381780066576 ()

  • 10 mm dia x 15 mm L
040010

  • Subtalar implant, non-bioabsorbable
The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement. The implant is indicated as an internal support in the treatment of flat foot, providing structural support.
Ascension Orthopedics, Inc.
040009
In Commercial Distribution

  • M2480400090 ()
  • 10381780066569 ()

  • 9 mm dia x 15 mm L
040009

  • Subtalar implant, non-bioabsorbable
The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement. The implant is indicated as an internal support in the treatment of flat foot, providing structural support.
Ascension Orthopedics, Inc.
040008
In Commercial Distribution

  • M2480400080 ()
  • 10381780066552 ()

  • 8 mm dia x 15 mm L
040008

  • Subtalar implant, non-bioabsorbable
Indications for FH: The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma. Indications for FSGS: The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA CORPORATION
LA-15
In Commercial Distribution

  • 24993478010117 ()
  • 14993478010110 ()
  • 04993478010113 ()
N/A

  • Haemoperfusion system absorption column
TUBING SET CEDTTS100 5PK US
MEDTRONIC, INC.
CEDTTS100
In Commercial Distribution

  • 00763000709181 ()
  • 20763000709185 ()


  • Cardiac ablation system irrigation tubing set
The Prismaflex TPE2000 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered), after having selected TPE therapy. The Prismaflex TPE2000 set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated.
GAMBRO INDUSTRIES
114093
In Commercial Distribution

  • 07332414111038 ()
  • 37332414111039 ()
114093

  • Apheresis system filter, whole blood
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