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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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INTEGRA Dermal Regeneration Template 4in. x 10in. (10cm x 25cm) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound.
Integra Lifesciences Corporation
34105
In Commercial Distribution

  • M269341051 ()
  • 10381780000594 ()
  • 00381780000597 ()

  • 4 in x 10 in
34105

  • Animal-derived wound matrix dressing
INTEGRA Dermal Regeneration Template 4in. x 5in. (10cm x 12.5cm) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound.
Integra Lifesciences Corporation
34055
In Commercial Distribution

  • M269340551 ()
  • 10381780000570 ()
  • 00381780000573 ()

  • 4 in x 5 in
34055

  • Animal-derived wound matrix dressing
INTEGRA Dermal Regeneration Template 2in. x 2in. (5cm x 5cm) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound.
Integra Lifesciences Corporation
32025
In Commercial Distribution

  • M269320251 ()
  • 10381780000556 ()
  • 00381780000559 ()

  • 2 in x 2 in
32025

  • Animal-derived wound matrix dressing
The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic arteries.
Shockwave Medical, Inc.
825Dx
In Commercial Distribution

  • 00195451000355 ()
IVLGCCDX

  • Intravascular lithotripsy system generator
ZOLL AED 3, SEMI-AUTOMATIC, ENGLISH, AHA, UNI-PADZ III, DEVICE DASHBOARD, LIFETIME OF PRODUCT, CLEVELAD CLINIC
Zoll Medical Corporation
8540-001101-01
In Commercial Distribution

  • 00847946092900 ()


  • Non-rechargeable public semi-automated external defibrillator
The FLOSEAL Malleable Tip and Trimmable Tip are intended for delivery of FLOSEAL Hemostatic Matrix.
BAXTER HEALTHCARE CORPORATION
1502186
In Commercial Distribution

  • 50085412091001 ()
  • 00085412091006 ()
1502186

  • Collagen haemostatic agent, non-antimicrobial
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Data Analysis Platform (CDAP) is a component of the Cordella Pulmonary Artery Sensor System. The Cordella Data Analysis Platform (CDAP) is a secure, cloud-based, standalone application that collects and stores raw Reader data and processes it according to pre-defined algorithms to convert it into final-form pulmonary artery pressure data.
Endotronix, Inc.
100543-00
In Commercial Distribution

  • 00850008997051 ()


  • Implantable pulmonary artery pressure monitoring system
Indications for FH: The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. 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 SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. 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 PHARMA AMERICA LLC
KP-05
In Commercial Distribution

  • 14537693900636 ()
  • 04537693900639 ()


  • Apheresis system filter, whole blood
The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries.
Shockwave Medical, Inc.
825D
In Commercial Distribution

IVLGCCD

  • Intravascular lithotripsy system balloon catheter, coronary
  • Intravascular lithotripsy system balloon catheter, peripheral
  • Intravascular lithotripsy system generator
The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries.
Shockwave Medical, Inc.
825D
In Commercial Distribution

  • M732IVLGCCD0 ()
IVLGCCD

  • Ultrasound thrombolysis system control unit
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