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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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Pink gutta percha core thermal obturator
US ENDODONTICS, LLC
EE4020C
In Commercial Distribution

  • 10810047644061 ()
  • 00810047644064 ()
EE4020C

  • Warm-bonded endodontic obturation system obturator
Pink gutta percha core thermal obturator
US ENDODONTICS, LLC
EE3520C
In Commercial Distribution

  • 10810047644054 ()
  • 00810047644057 ()
EE3520C

  • Warm-bonded endodontic obturation system obturator
Pink gutta percha core thermal obturator
US ENDODONTICS, LLC
EE3020C
In Commercial Distribution

  • 10810047644047 ()
  • 00810047644040 ()
EE3020C

  • Warm-bonded endodontic obturation system obturator
Pink gutta percha core thermal obturator
US ENDODONTICS, LLC
EE2520C
In Commercial Distribution

  • 10810047644030 ()
  • 00810047644033 ()
EE2520C

  • Warm-bonded endodontic obturation system obturator
Pink gutta percha core thermal obturator
US ENDODONTICS, LLC
EE2020C
In Commercial Distribution

  • 10810047643880 ()
  • 00810047643883 ()
EE2020C

  • Warm-bonded endodontic obturation system obturator
Pacemaker
BOSTON SCIENTIFIC CORPORATION
S205
In Commercial Distribution

  • 00802526499210 ()


  • Dual-chamber implantable pacemaker, rate-responsive
Pacemaker
BOSTON SCIENTIFIC CORPORATION
S204
In Commercial Distribution

  • 00802526499128 ()


  • Single-chamber implantable pacemaker, rate-responsive
Pacemaker
BOSTON SCIENTIFIC CORPORATION
S208
In Commercial Distribution

  • 00802526484421 ()


  • Dual-chamber implantable pacemaker, rate-responsive
Pacemaker
BOSTON SCIENTIFIC CORPORATION
S203
In Commercial Distribution

  • 00802526484391 ()


  • Dual-chamber implantable pacemaker, rate-responsive
Pacemaker
BOSTON SCIENTIFIC CORPORATION
S201
In Commercial Distribution

  • 00802526484384 ()


  • Single-chamber implantable pacemaker, rate-responsive
No Description
Atos Medical AB
8343
In Commercial Distribution

  • 07331791181184 ()
8343

  • Tracheoesophageal fistula dilator, reusable
Provox XtraFlange is a white silicone washer that is intended to be placed between the tracheal flange of the prosthesis and the tracheal mucosa. It provides an extra seal against periprosthetic leakage through the adherence of the thin silicone sheet to the tracheal mucosa. The device is supplied sterile and is intended for single use only.
Atos Medical AB
7276
In Commercial Distribution

  • 07331791006937 ()

  • Voice Prosthesis Compatibility Fits 20 Fr voice prosthesis
7276

  • Tracheoesophageal speech valve, indwelling
The Provox voice prosthesis system is intended for use of prosthetic voice restoration after total laryngectomy. The Provox Dilator 17 and 20 are used for dilating tracheo-esophageal (TE) punctures that shrinks very fast or are too narrow to insert the selected Provox voice prosthesis. The Dilator may also be used to temporarily block or stent the TE puncture.
Atos Medical AB
7123
In Commercial Distribution

  • 07331791000409 ()
7123

  • Tracheoesophageal fistula dilator, reusable
No Description
WEST PHARMA. SERVICES IL, . LTD
8074029
In Commercial Distribution

  • 07290108240771 ()


  • Vial/bottle adaptor, hermetic
COPILOT Kit includes Bleedback Control Valve 20/30 INDEFLATOR Inflation Device 30 atm 20 cc / Guide Wire Introducer / Torque Device
ABBOTT VASCULAR INC.
1003327
In Commercial Distribution

  • 08717648013973 ()
1003327

  • Catheter/overtube balloon inflator, single-use
HYDROGEL COATED LATEX FOLEY CATHETER, 30 CC, 2-WAY, 20 FR (6.7 MM)
Cardinal Health 200, LLC
1420
In Commercial Distribution

  • 20192253026068 ()
  • 10192253026061 ()
  • 50192253026069 ()
1420-

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
HYDROGEL COATED LATEX FOLEY CATHETER, 5 CC, 3-WAY, 20 FR (6.7 MM)
Cardinal Health 200, LLC
2720
In Commercial Distribution

  • 20192253026242 ()
  • 10192253026245 ()
  • 50192253026243 ()
2720-

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
The Durette® ocular implant, made of clear acrylic material (PMMA), is a smooth-surface motility implant used for enucleation, evisceration, and secondary implantation. There are two 20 mm diameter models that are quasi-spherical: Model I, which has a slightly flattened smooth anterior surface (1 mm flatter vs. a sphere); and Model IV, which has four pronounced mounds (within the sphere) for optimal coupling and motility. The implants have a network of 20 interconnected tunnels (1 to 2 mm) offering the eye surgeon with 3 levels for suturing each rectus muscle, and allowing new tissue to form and integrate with surrounding tissue, while aiming to prevent migration, forward displacement and tissue stretching. They both have an off-center medial posterior elongation for added volume and better front positioning of details for coupling with ocular prostheses.
Oculo-Plastik Inc
12-420
Not in Commercial Distribution


  • Outer Diameter: 20 Millimeter
  • Total Volume: 3.5 Milliliter


  • Orbital sphere implant
The Durette® ocular implant, made of clear acrylic material (PMMA), is a smooth-surface motility implant used for enucleation, evisceration, and secondary implantation. There are two 20 mm diameter models that are quasi-spherical: Model I, which has a slightly flattened smooth anterior surface (1 mm flatter vs. a sphere); and Model IV, which has four pronounced mounds (within the sphere) for optimal coupling and motility. The implants have a network of 20 interconnected tunnels (1 to 2 mm) offering the eye surgeon with 3 levels for suturing each rectus muscle, and allowing new tissue to form and integrate with surrounding tissue, while aiming to prevent migration, forward displacement and tissue stretching. They both have an off-center medial posterior elongation for added volume and better front positioning of details for coupling with ocular prostheses.
Oculo-Plastik Inc
12-120
Not in Commercial Distribution


  • Outer Diameter: 20 Millimeter
  • Total Volume: 4 Milliliter


  • Orbital sphere implant
ABSORBENT POINTS (200/box) Type: ISO, Size: 20; For more information: https://www.scottsdental.com/catalog/product/view/id/23513/s/absorbent-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9063
In Commercial Distribution

  • D77810390630 ()
  • D77810390631 ()
103-9063

  • Endodontic paper point
The Durette® ocular implant, made of clear acrylic material (PMMA), is a smooth-surface motility implant used for enucleation, evisceration, and secondary implantation. There are two 20 mm diameter models that are quasi-spherical: Model I, which has a slightly flattened smooth anterior surface (1 mm flatter vs. a sphere); and Model IV, which has four pronounced mounds (within the sphere) for optimal coupling and motility. The implants have a network of 20 interconnected tunnels (1 to 2 mm) offering the eye surgeon with 3 levels for suturing each rectus muscle, and allowing new tissue to form and integrate with surrounding tissue, while aiming to prevent migration, forward displacement and tissue stretching. They both have an off-center medial posterior elongation for added volume and better front positioning of details for coupling with ocular prostheses.
Oculo-Plastik Inc
12-420
Not in Commercial Distribution

  • M8721242003 ()

  • Total Volume: 3.5 Milliliter
  • Outer Diameter: 20 Millimeter


  • Orbital sphere implant
The Durette® ocular implant, made of clear acrylic material (PMMA), is a smooth-surface motility implant used for enucleation, evisceration, and secondary implantation. There are two 20 mm diameter models that are quasi-spherical: Model I, which has a slightly flattened smooth anterior surface (1 mm flatter vs. a sphere); and Model IV, which has four pronounced mounds (within the sphere) for optimal coupling and motility. The implants have a network of 20 interconnected tunnels (1 to 2 mm) offering the eye surgeon with 3 levels for suturing each rectus muscle, and allowing new tissue to form and integrate with surrounding tissue, while aiming to prevent migration, forward displacement and tissue stretching. They both have an off-center medial posterior elongation for added volume and better front positioning of details for coupling with ocular prostheses.
Oculo-Plastik Inc
12-120
Not in Commercial Distribution

  • M8721212000 ()

  • Total Volume: 4 Milliliter
  • Outer Diameter: 20 Millimeter


  • Orbital sphere implant
nextaro® v, 20/20 (with 5 µm filter)
sfm medical devices GmbH
20040
In Commercial Distribution

  • 04063574200401 ()


  • Medication transfer set
3D Fusion™ Firm Matrix Band Special Kit: 80 Count (20) FXH100, (20) FXH175, (20) FXH200, (20) FXH300
GARRISON DENTAL SOLUTIONS, L.L.C.
FXHB03
In Commercial Distribution

  • 00810038095349 ()
FXHB03

  • Dental matrix band, single-use
A hand-held manual ophthalmic instrument designed to hold and insert an orbital sphere implant into the orbital cavity (eye socket). It typically has a body made of high-grade stainless steel with a piston used to forward the implant, which is held and positioned by the size-adjustable head of the device. This is a reusable device.
FCI S A S FCI 20 22
S6.3050
In Commercial Distribution

  • 13760087126386 ()


  • Orbital sphere implant introducer
A hand-held manual ophthalmic surgical instrument with small blades designed to grasp and manipulate ophthalmic implants (excluding sutures) during implantation/explantation; it is not intended for use on tissues. Its design may be tweezers-like, or it may be probe-like with a proximal handle, a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a reusable device intended to be sterilized prior to use.
FCI S A S FCI 20 22
S5.3100
In Commercial Distribution

  • 13760087126294 ()


  • Ophthalmic implant handling forceps, reusable
A slender hand-held manual instrument with a hook at its distal end designed to be inserted through the nose to extract a tube, cannula, or probe previously inserted into the lacrimal drainage system (the lacrimal duct), by pulling it out through the nose. This is a reusable device.
FCI S A S FCI 20 22
S1.1480
In Commercial Distribution

  • 13760087126256 ()


  • Transnasal lacrimal tube extractor
A hand-held manual ophthalmic surgical instrument with small blades designed to grasp and manipulate ophthalmic implants (excluding sutures) during implantation/explantation; it is not intended for use on tissues. Its design may be tweezers-like, or it may be probe-like with a proximal handle, a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a reusable device intended to be sterilized prior to use.
FCI S A S FCI 20 22
S1.1470
In Commercial Distribution

  • 13760087126249 ()


  • Ophthalmic implant handling forceps, reusable
A hand-held, manual, slender rod-like ophthalmic surgical instrument made of flexible metal, with a blunt bulbous tip, used for exploring the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device.
FCI S A S FCI 20 22
S1.1460
In Commercial Distribution

  • 13760087126232 ()


  • Ophthalmic surgical probe, reusable
No Description
FCI S A S FCI 20 22
S1.1275
In Commercial Distribution

  • 13760087126225 ()


  • Transnasal lacrimal tube extractor
No Description
FCI S A S FCI 20 22
A8.4050
In Commercial Distribution

  • 13760087126072 ()


  • Ophthalmic surgical probe, reusable
No Description
FCI S A S FCI 20 22
S1.4132
In Commercial Distribution

  • 13760087123842 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4131
In Commercial Distribution

  • 13760087123835 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4122
In Commercial Distribution

  • 13760087123828 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4121
In Commercial Distribution

  • 13760087123811 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4132
In Commercial Distribution



  • Ophthalmic surgical procedure kit, non-medicated, single-use
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4131
In Commercial Distribution



  • Ophthalmic surgical procedure kit, non-medicated, single-use
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4122
In Commercial Distribution



  • Ophthalmic surgical procedure kit, non-medicated, single-use
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
FCI S A S FCI 20 22
S1.4121
In Commercial Distribution

  • 13700773735096 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
Punctum plug
FCI S A S FCI 20 22
S2.3882
In Commercial Distribution

  • 23700773734805 ()
  • 13700773734808 ()


  • Lacrimal punctum plug
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