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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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Quantum Pump Frame 6 - Toronto
SPECTRUM MEDICAL LIMITED
QPF6
In Commercial Distribution

  • 05060434422316 ()
51-000095-00

  • Cardiopulmonary bypass system roller pump
Quantum Pump Frame 5 - Charlotte
SPECTRUM MEDICAL LIMITED
QPF5
In Commercial Distribution

  • 05060434422262 ()
51-000090-00

  • Cardiopulmonary bypass system roller pump
Quantum Pump Frame 2 - Cheltenham
SPECTRUM MEDICAL LIMITED
QPF2
In Commercial Distribution

  • 05060434422040 ()
51-000025-01

  • Cardiopulmonary bypass system roller pump
Quantum Roller Pump - 8 inch
SPECTRUM MEDICAL LIMITED
QRP8
In Commercial Distribution

  • 05060434420770 ()
51-000008-00

  • Cardiopulmonary bypass system roller pump
Quantum Pump Frame 2 - Cheltenham
SPECTRUM MEDICAL LIMITED
QPF2
In Commercial Distribution

  • 05060434420756 ()
51-000025-00

  • Cardiopulmonary bypass system roller pump
Single Use Medical Device for Ophthalmic Surgery
Bausch & Lomb GmbH
SUJ13
In Commercial Distribution

  • 24058935005645 ()
  • 04058935005641 ()
SUJ13

  • Vitrectomy fluid/gas handling handpiece/cannula
Single Use Medical Device for Ophthalmic Surgery
Bausch & Lomb GmbH
SUJ12
In Commercial Distribution

  • 24058935005621 ()
  • 04058935005627 ()
SUJ12

  • Vitrectomy fluid/gas handling handpiece/cannula
Single Use Medical Device for Ophthalmic Surgery
Bausch & Lomb GmbH
SUJ11
In Commercial Distribution

  • 24058935005607 ()
  • 04058935005603 ()
SUJ11

  • Vitrectomy fluid/gas handling handpiece/cannula
Single Use Medical Device for Ophthalmic Surgery
Bausch & Lomb GmbH
SUJ09
In Commercial Distribution

  • 24058935005560 ()
  • 04058935005566 ()
SUJ09

  • Vitrectomy fluid/gas handling handpiece/cannula
Single Use Medical Device for Ophthalmic Surgery
Bausch & Lomb GmbH
SUJ03
In Commercial Distribution

  • 24058935005485 ()
  • 04058935005481 ()
SUJ03

  • Vitrectomy fluid/gas handling handpiece/cannula
Single Use Medical Device for Ophthalmic Surgery
Bausch & Lomb GmbH
SUJ01
In Commercial Distribution

  • 24058935005447 ()
  • 04058935005443 ()
SUJ01

  • Vitrectomy fluid/gas handling handpiece/cannula
Single Use Medical Device for Ophthalmic Surgery
Bausch & Lomb GmbH
SUJ14
In Commercial Distribution

  • 24058935005669 ()
  • 04058935005665 ()
SUJ14

  • Vitrectomy fluid/gas handling handpiece/cannula
No Description
Bausch & Lomb GmbH
SUJ10
In Commercial Distribution

  • 24058935005584 ()
  • 04058935005580 ()
SUJ10

  • Vitrectomy fluid/gas handling handpiece/cannula
Single Use Medical Device for Ophthalmic Surgery
Bausch & Lomb GmbH
SUJ08
In Commercial Distribution

  • 24058935005546 ()
  • 04058935005542 ()
SUJ08

  • Vitrectomy fluid/gas handling handpiece/cannula
Single Use Medical Device for Ophthalmic Surgery
Bausch & Lomb GmbH
SUJ02
In Commercial Distribution

  • 24058935005461 ()
  • 04058935005467 ()
SUJ02

  • Vitrectomy fluid/gas handling handpiece/cannula
The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 6.0mm, Length = 150mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
LA18-05060150
In Commercial Distribution

  • 04543660026530 ()
LA18-05060150

  • Peripheral angioplasty balloon catheter, basic
The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 6.0mm, Length = 100mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
LA18-05060100
In Commercial Distribution

  • 04543660026523 ()
LA18-05060100

  • Peripheral angioplasty balloon catheter, basic
The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 5.0mm, Length = 150mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
LA18-05050150
In Commercial Distribution

  • 04543660026516 ()
LA18-05050150

  • Peripheral angioplasty balloon catheter, basic
The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 145cm, Diameter = 6.0mm, Length = 100mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
LW18-14560100
In Commercial Distribution

  • 04543660026462 ()
LW18-14560100

  • Peripheral angioplasty balloon catheter, basic
The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 145cm, Diameter = 5.0mm, Length = 150mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
LW18-14550150
In Commercial Distribution

  • 04543660026455 ()
LW18-14550150

  • Peripheral angioplasty balloon catheter, basic
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