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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532nm Heine Omega Indirect Ophthalmoscope with integrated adaptor
QUANTEL MEDICAL
IOH810532
In Commercial Distribution

  • 03700542625224 ()


  • Indirect binocular laser ophthalmoscope
Fold away 532nm adaptor for OPTIMIS FUSION (Single Spot)
QUANTEL MEDICAL
FUSION LINK (FUS1)
In Commercial Distribution

  • 03700542625217 ()


  • Laser adaptor
532nm adaptor for OPTIMIS II (Single Spot)
QUANTEL MEDICAL
532OPT2STD
In Commercial Distribution

  • 03700542625200 ()


  • Laser adaptor
532nm adaptor for CSO 980 Slit Lamp (Single Spot)
QUANTEL MEDICAL
532CSO3ST
In Commercial Distribution

  • 03700542625194 ()


  • Laser adaptor
532nm adaptor for ZEISS 130 Slit Lamp (Single Spot)
QUANTEL MEDICAL
532CZ130
In Commercial Distribution

  • 03700542625187 ()


  • Laser adaptor
532nm adaptor for ZEISS 120 Slit Lamp (Single Spot)
QUANTEL MEDICAL
532CZ120
In Commercial Distribution

  • 03700542625170 ()


  • Laser adaptor
532nm adaptor for ZEISS 30 Slit Lamp (Single Spot)
QUANTEL MEDICAL
532CZ30
In Commercial Distribution

  • 03700542625163 ()


  • Laser adaptor
Fold away 532nm adaptor for HS900 BM/BQ Slit Lamp (Single Spot)
QUANTEL MEDICAL
532HSDST
In Commercial Distribution

  • 03700542625156 ()


  • Laser adaptor
Fixed 532nm adaptor for HS900 BM/BQ Slit Lamp (Single Spot)
QUANTEL MEDICAL
532BMBQMST2
In Commercial Distribution

  • 03700542625149 ()


  • Laser adaptor
Ophthalmic Laser Photocoagulator 532nm MonoSpot Laser Retinal Photocoagulation
QUANTEL MEDICAL
VITRA
In Commercial Distribution

  • 03700542625132 ()


  • Ophthalmic solid-state laser system
Corneal thickness measurement probe.
QUANTEL MEDICAL
P1
In Commercial Distribution

  • 03700542625125 ()


  • Ophthalmic ultrasound imaging transducer
Digitally programmed S-shaped amplifier characteristics and comprehensive design criteria for standardized echography and tissue differentiation according to Karl C. Ossoinig MD
QUANTEL MEDICAL
Std-A
In Commercial Distribution

  • 03700542625118 ()


  • Ophthalmic ultrasound imaging transducer
Axial length measurement probe with an integrated laser pointer for biometry: - Ensuring the acquisition in the visual axis - Increasing the patient cooperation - Accelerating the speed of acquisition of A scans
QUANTEL MEDICAL
TP-02-las
In Commercial Distribution

  • 03700542625101 ()


  • Ophthalmic ultrasound imaging transducer
Axial length measurement probe.
QUANTEL MEDICAL
TP-01 / TP-01-b
In Commercial Distribution

  • 03700542625095 ()


  • Ophthalmic ultrasound imaging transducer
50 MHz probe reveals what you can not see with OCT alone, enabling the operator to visualize the structures located behind the iris such as ciliary bodies, the processes and lens zonules. Linear scanning offers the greatest signal intensity, providing superior anterior chamber image quality as the probe is always perpendicular with the tissue interface of interest.
QUANTEL MEDICAL
BHF-50LIN AVISO
In Commercial Distribution

  • 03700542625088 ()


  • Ophthalmic ultrasound imaging transducer
10 MHz Probe for eye and orbit examination. Automatic biometry readings obtained from a B mode image allowing axial length measurements for difficult to mesure long eyes or posterior staphyloma.
QUANTEL MEDICAL
B1 COMPACT TOUCH
In Commercial Distribution

  • 03700542625071 ()


  • Ophthalmic ultrasound imaging transducer
No Description
QUANTEL MEDICAL
B-HF AVISO
In Commercial Distribution

  • 03700542625064 ()


  • Ophthalmic ultrasound imaging transducer
10 MHz Probe for eye and orbit examination. Automatic biometry readings obtained from a B mode image allowing axial length measurements for difficult to mesure long eyes or posterior staphyloma.
QUANTEL MEDICAL
B1 AVISO
In Commercial Distribution

  • 03700542625057 ()


  • Ophthalmic ultrasound imaging transducer
Ultrasonic Pachymeter for Glaucoma Screening and Refractive Surgery.
QUANTEL MEDICAL
POCKET II
In Commercial Distribution

  • 03700542625040 ()


  • Ultrasound pachymeter
Ophthalmic Ultrasound Biometer: Biometry and IOL Calculation The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including: • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement.
QUANTEL MEDICAL
AXIS NANO
In Commercial Distribution

  • 03700542625033 ()


  • Ophthalmic ultrasound imaging system
Ophthalmic Ultrasound Biomicroscope UBM and automatic STS measurement for ICL sizing The QUANTEL MEDICAL Compact Touch STS UBMTM Ophthalmic Ultrasound System (and its associated Linear 50 MHz probe) is intended to be used for diagnostic imaging and measurement of the eye including: • Visualization of the interior of the eye by B scans. • Make measurements inside the eye (Sulcus to Sulcus, Irido Cornea Angle Left, Irido Cornea Angle Right, Lens curvature and Anterior Chamber depth).
QUANTEL MEDICAL
COMPACT TOUCH STS UBM
In Commercial Distribution

  • 03700542625026 ()


  • Ophthalmic ultrasound imaging system
Ophthalmic Ultrasound System: A/B Scan and Pachymetry The QUANTEL MEDICAL COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: • Visualization of the interior of the eye and the orbit by A and B scans. • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement. • Measurement of corneal thickness by ultrasonic means.
QUANTEL MEDICAL
COMPACT TOUCH
In Commercial Distribution

  • 03700542625019 ()


  • Ophthalmic ultrasound imaging system
AVISO (S) Ophthalmic A (A-Std), B Scan and UBM Ultrasound System The QUANTEL MEDICAL AVISO modular platform is an ultrasound system intended to be used for: • Axial Length measurement of the eye by ultrasonic means • Implanted IOL power calculation, using the Axial Length measurement • Visualization of the interior of the eye and the orbit by A and B scans (• Advanced diagnostic: standardized echography provides detailed information about the internal reflectivity of tissues and allows optimal tissues differentiation, localization and measurement of structures in the eye and orbit.)
QUANTEL MEDICAL
AVISO (S)
In Commercial Distribution

  • 03700542625002 ()


  • Ophthalmic ultrasound imaging system
No Description
FIM MEDICAL
EXPERT DEPISTEO
In Commercial Distribution

  • 03760253450621 ()


  • Pulmonary function analysis system, adult
No Description
FIM MEDICAL
Expert
In Commercial Distribution

  • 03760253450614 ()


  • Pulmonary function analysis system, adult
No Description
FIM MEDICAL
EXPERT DEPISTEO
In Commercial Distribution

  • 03760253450607 ()


  • Pulmonary function analysis system, adult
Single patient use spirometry sensor
FIM MEDICAL
QFLOW
In Commercial Distribution

  • 03760253450195 ()
  • 03760253450188 ()


  • Pulmonary function testing filter/mouthpiece
No Description
FIM MEDICAL
Expert
Not in Commercial Distribution

  • 03760253450010 ()


  • Pulmonary function analysis system, adult
No Description
FIM MEDICAL
Q13
In Commercial Distribution

  • 03760253450003 ()


  • Pulmonary function analysis system, adult
RespIn 11 Bronchial Airway Clearance System is a "Focused Pulse" High Frequency Chest Wall Oscillation (HFCWO) device that maximizes the use of modern technologies and materials to produce a more comfortable, flexible and effective therapy delivery system.
RESPINNOVATION
11
In Commercial Distribution

  • 03760251321107 ()


  • Chest-oscillation airway secretion-clearing system
Sulcular opening paste (x6 capsules).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243007033 ()
  • 03760243005008 ()
  • 03760243009808 ()
294010

  • Gingival retraction kit
Disposable single use tips for air/water syringe (dental).
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009907 ()
  • 03760243001093 ()
201669

  • Surgical mist irrigation tip
Expasyl is a paste for temporary gingival retraction that ensures separation of the marginal gingiva and drying of the sulcus
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL EXACT
In Commercial Distribution

  • 03760243001048 ()
  • 03760243007170 ()
  • 03760243007187 ()
  • 03760243007194 ()


  • Gingival retraction kit
HEMOSTASYL is a paste to be used as a haemostatic dressing with a mechanical action. Kit containing: 2 x 2g syringes of HEMOSTASYL Paste (about 30 uses) and 40 HEMOSTASYL angled application cannulas. Syringe for multiple uses. Application cannulas for single use.
PRODUITS DENTAIRES PIERRE ROLLAN
Hemostasyl Kit
Not in Commercial Distribution

  • 03760243000959 ()
246200

  • Non-organic haemostatic agent
box with 40 angled application cannulas for Hemostasyl paste in syringe
PRODUITS DENTAIRES PIERRE ROLLAN
Hemostasyl canula
Not in Commercial Distribution

  • 03760243000942 ()
246100

  • Dental material injection cannula, single-use
HEMOSTASYL is an original paste to be used as a haemostatic dressing with a mechanical action. Box with 2 x 2g multiple use syringes of HEMOSTASYL paste
PRODUITS DENTAIRES PIERRE ROLLAN
Hemostasyl syringes
Not in Commercial Distribution

  • 03760243000935 ()
  • 03760243007125 ()
246050

  • Non-organic haemostatic agent
6 capsules (sulcular opening paste) + 1 applicator + 12 application cannulas.
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243000775 ()
294100

  • Gingival retraction kit
Expasyl bended application cannulas x100 for EXPASYL paste (sulcular opening paste).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243009839 ()
  • 03760243000751 ()
261015

  • Dental material injection cannula, single-use
Expasyl bended application cannulas x40 for EXPASYL paste (sulcular opening paste).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243009839 ()
  • 03760243000744 ()
261045

  • Dental material injection cannula, single-use
Expasyl straight application cannulas x100 for EXPASYL paste (sulcular opening paste).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243009822 ()
  • 03760243000737 ()
261005

  • Dental material injection cannula, single-use
Expasyl straight application cannulas x40 for EXPASYL paste (sulcular opening paste).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243009822 ()
  • 03760243000720 ()
261040

  • Dental material injection cannula, single-use
Sulcular opening paste (x20 capsules).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243007040 ()
  • 03760243000713 ()
  • 03760243009815 ()
261001

  • Gingival retraction kit
Sulcular opening paste (x20 capsules).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243009808 ()
  • 03760243000706 ()
  • 03760243007026 ()
261030

  • Gingival retraction kit
Disposable single use tips with sheath for air/water syringe
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243000553 ()
  • 03760243009976 ()
201751

  • Surgical mist irrigation tip
Disposable single use tips with sheath for air/water syringe.
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009969 ()
  • 03760243000546 ()
201750

  • Surgical mist irrigation tip
Disposable single use tips for air/water syringe.
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009952 ()
  • 03760243000539 ()
201668

  • Surgical mist irrigation tip
Disposable single use tips for air/water syringe
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009945 ()
  • 03760243000522 ()
201667

  • Surgical mist irrigation tip
Disposable single use tips for air/water syringe
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009938 ()
  • 03760243000515 ()
201666

  • Surgical mist irrigation tip
Disposable single use tips for air/water syringe
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009921 ()
  • 03760243000508 ()
201665

  • Surgical mist irrigation tip
Disposable single use tips for air/water syringe
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009914 ()
  • 03760243000492 ()
201664

  • Surgical mist irrigation tip
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