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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Perseus Device Sensor
ORTHOKEY ITALIA SRL
20100801
In Commercial Distribution

  • 08052675960013 ()
20100801

  • Orthopaedic stereotactic surgery system
The MOTUS PRO AX is a medical laser equipped with Alexandrite 755nm laser only. The laser sources deliver the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition.
DEKA M.E.L.A. SRL
M130P1
In Commercial Distribution

  • 08034108512907 ()


  • Multi-modality skin surface treatment system
The MOTUS PRO is a medical laser equipped with Alexandrite 755nm laser and Nd:YAG 1064nm laser. The laser sources deliver the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition.
DEKA M.E.L.A. SRL
M130N1
In Commercial Distribution

  • 08034108512891 ()


  • Multi-modality skin surface treatment system
The SMARTXIDE TETRA PRO DEVICE consists of a 10,600nm carbon dioxide laser (CO2) laser with 40W of maximum power. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end. The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis regardless of the arm orientation. The device may be used in combination with scanning units in order to achieve greater predictability and reproducibility. The use with the scanning units is indicated for layer-by-layer char-free ablation, enhancing the safety of the treatment with more uniform, accurate and controllable impact such as ablative skin resurfacing.
DEKA M.E.L.A. SRL
M118G1
In Commercial Distribution

  • 08034108512808 ()


  • General/multiple surgical carbon dioxide laser system
The SmartXide PRO is a medical device indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues incluing intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
DEKA M.E.L.A. SRL
M079BI1
In Commercial Distribution

  • 08034108512709 ()
M079R1

  • Dermatological carbon dioxide laser system
The Elite iQ PRO Laser System is indicated fot stable long-term or permanent hair reduction. Peramanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 or 12 months after the completiomn of a treatment regime. It is used for skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. 1064nm: The Elite iQ PRO Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lakes, leg veins, spider wine and poikiloderma of Civatte; and treatment of benign cutaneous lesions such as, but not limited to, lentigines (age spots), solar lentigines (sunspots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the treatment of psuedo folliculitis barbae (PFB) and for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6,9 and 12 months after the competition of a treatment regime. The Skintel Reader is intended as an onbjective measurement tool for examing skin melanin content for determing and setting a test spot starting fluence.
DEKA M.E.L.A. SRL
M122K1
In Commercial Distribution

  • 08034108512655 ()
M122K1

  • Multi-modality skin surface treatment system
The DEKA AGAIN PRO family is a medical laser family equipped with Alexandrite 755nm laser and Nd:YAG 1064nm laser. The laser sources deliver the laser output through a lens coupled user repleaceable optical fiber with a wider range of intercheangeable, quick release laser handpieces with electronic spot recognition.
DEKA M.E.L.A. SRL
M126AA1
In Commercial Distribution

  • 08034108512525 ()


  • Multi-modality skin surface treatment system
The device is a camera system specifically intended to examine the oral cavity. This system is designed to allow the dentist to more efficiently show and explain to patients all oral conditions and reasons for planned treatment.
CEFLA SOCIETA' COOPERATIVA
C-U2
In Commercial Distribution

  • 08033837930174 ()
70220000

  • Intraoral camera
I-MAX 3D CEPH version
OWANDY RADIOLOGY
I-MAX 3D PAN CEPH 110-120V
In Commercial Distribution

  • 03760262651828 ()
9304301011

  • Stationary panoramic/tomographic dental x-ray system, digital
I-MAX 3D PAN version 100-120V with floor-mounted column
OWANDY RADIOLOGY
I-MAX 3D PAN ONLY FLOOR 100-120V
In Commercial Distribution

  • 03760262651804 ()
9304100011.FL

  • Stationary panoramic/tomographic dental x-ray system, digital
I-MAX CEPH version with double sensor
OWANDY RADIOLOGY
I-MAX PAN CEPH DOUBLE SENSOR 110-120V
In Commercial Distribution

  • 03760262651637 ()
9304201011.DS

  • Stationary panoramic/tomographic dental x-ray system, digital
I-MAX CEPH version
OWANDY RADIOLOGY
I-MAX PAN CEPH 110-120V
In Commercial Distribution

  • 03760262651620 ()
9304201011

  • Stationary panoramic/tomographic dental x-ray system, digital
I-MAX PAN version 100-120V with floor-mounted column
OWANDY RADIOLOGY
I-MAX PAN ONLY FLOOR 100-120V
In Commercial Distribution

  • 03760262651606 ()
9304000011.FL

  • Stationary panoramic/tomographic dental x-ray system, digital
Owandy-RX PRO CORE KIT SC NO BRACKET
OWANDY RADIOLOGY
Owandy-RX PRO CORE KIT SC NO BRACKET
In Commercial Distribution

  • 03760262650661 ()
W0806091

  • Stationary intraoral dental x-ray system, digital
Owandy-RX PRO TOP 110 SHORT CONE, with interface wall plate (16")
OWANDY RADIOLOGY
OWANDY-RX PRO TOP 110 SHORT CONE, INTERF WALL PLATE (16”)
In Commercial Distribution

  • 03760262650654 ()
W0806002

  • Stationary intraoral dental x-ray system, digital
Owandy-RX PRO TOP 80 SHORT CONE, with interface wall plate (16")
OWANDY RADIOLOGY
OWANDY-RX PRO TOP 80 SHORT CONE, INTERF WALL PLATE (16”)
In Commercial Distribution

  • 03760262650647 ()
W0806001

  • Stationary intraoral dental x-ray system, digital
Owandy-RX PRO TOP 40 SHORT CONE, with interface wall plate (16")
OWANDY RADIOLOGY
OWANDY-RX PRO TOP 40 SHORT CONE, INTERF WALL PLATE (16”)
In Commercial Distribution

  • 03760262650630 ()
W0806000

  • Stationary intraoral dental x-ray system, digital
K Push is a hand held dynamometer used for the evaluation of muscles strength. You can assess isometric strength by the way of the peak force as well as of the average force for a specific muscle or muscle groups. The K Push allows to quantitatively measure the muscle strength and the deficit percentage caused by injury compared to the strength of the healthy side.
KINVENT BIOMECANIQUE
K Push V3
In Commercial Distribution

  • 03770011995370 ()


  • Back/leg/chest dynamometer, electronic
Cardiac Electrophysiology mapping tool
SUBSTRATE HD
A002
In Commercial Distribution

  • 03770019196038 ()
A002

  • Cardiac mapping system computer
Cardiac Electrophysiology mapping tool
SUBSTRATE HD
A001
In Commercial Distribution

  • 03770019196007 ()
A001

  • Cardiac mapping system computer
K Myo is a biofeedback device for training muscle groups by means of electromyography
KINVENT BIOMECANIQUE
K Myo Black V3
In Commercial Distribution

  • 03770011995875 ()


  • Electromyograph
K Myo is a biofeedback device for training muscle groups by means of electromyography
KINVENT BIOMECANIQUE
K Myo V3
In Commercial Distribution

  • 03770011995707 ()


  • Electromyograph
K Deltas are two large independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength
KINVENT BIOMECANIQUE
K Deltas XL V3
In Commercial Distribution

  • 03770011995608 ()


  • Biomechanical function analysis system, force-testing, portable
K Move is an inertial sensor to measure the range of motion and to compare the symmetry between the injured limb’s amplitude and the healthy limb.
KINVENT BIOMECANIQUE
K Move V3
In Commercial Distribution

  • 03770011995462 ()


  • Electronic goniometer/kinesiology sensor
K Bubble is a pneumatic sensor allowing to work your strength with convenient inflatable tools.
KINVENT BIOMECANIQUE
K Bubble V3
In Commercial Distribution

  • 03770011995455 ()


  • Back/leg/chest dynamometer, electronic
K Grip is used for the evaluation of hand grip strength. You can assess isometric strength by the way of the peak force as well as of the average force. The K Grip dynamometer allows to quantitatively measure the grip weakness caused by injury compared to the strength of the healthy hand."
KINVENT BIOMECANIQUE
K Grip V3
In Commercial Distribution

  • 03770011995431 ()


  • Hand dynamometer/pinchmeter, electronic
K Pull is a traction dynamometer for the measurement of isometric strength and biofeedback training. K Pull enables independent measurements. It can be fixed on a physiotherapists table, on the espalier or on pulley machines.
KINVENT BIOMECANIQUE
K Pull V3
In Commercial Distribution

  • 03770011995424 ()


  • Back/leg/chest dynamometer, electronic
K Deltas are two large independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength
KINVENT BIOMECANIQUE
K Deltas V3
In Commercial Distribution

  • 03770011995417 ()


  • Biomechanical function analysis system, force-testing, portable
K Plates are two independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength
KINVENT BIOMECANIQUE
K Force Plates V3
In Commercial Distribution

  • 03770011995387 ()


  • Biomechanical function analysis system, force-testing, portable
TC100CS Mobile Cabinet, 33.5"h x 34.5"w x 21"d
Medical Technology Industries, Inc.
TC100CS
In Commercial Distribution

  • 10840118429570 ()
TC100CS

  • ENT cabinet
TC100BT Mobile Cabinet, 41"h x 24"w x 18"d
Medical Technology Industries, Inc.
TC100BT
In Commercial Distribution

  • 10840118429563 ()
TC100BT

  • ENT cabinet
TC100BS Mobile Cabinet, 41"h x 24"w x 21"d
Medical Technology Industries, Inc.
TC100BS
In Commercial Distribution

  • 10840118429556 ()
TC100BS

  • ENT cabinet
TC100AT Mobile Cabinet, 33.5"h x 24"w x 18"d
Medical Technology Industries, Inc.
TC100AT
In Commercial Distribution

  • 10840118429549 ()
TC100AT

  • ENT cabinet
TC100AS Mobile Cabinet, 33.5"h x 24"w x 21"d
Medical Technology Industries, Inc.
TC100AS
In Commercial Distribution

  • 10840118429532 ()
TC100AS

  • ENT cabinet
Exam Light, CLARUS 7 LED w/Floor Stand
Medical Technology Industries, Inc.
1000213
In Commercial Distribution

  • 10840118404881 ()
1000213

  • Fixed examination/treatment room light
Exam Light, CLARUS 7 LED w/Caster Base
Medical Technology Industries, Inc.
1000212
In Commercial Distribution

  • 10840118404874 ()
1000212

  • Fixed examination/treatment room light
Exam Light, CLARUS 4 LED w/Floor Stand
Medical Technology Industries, Inc.
1000211
In Commercial Distribution

  • 10840118404867 ()
1000211

  • Fixed examination/treatment room light
Exam Light, CLARUS 4 LED w/Caster Base
Medical Technology Industries, Inc.
1000210
In Commercial Distribution

  • 10840118404850 ()
1000210

  • Fixed examination/treatment room light
Exam Light, 42" LUMERUS LED f/1" Posts
Medical Technology Industries, Inc.
1000207
In Commercial Distribution

  • 10840118404843 ()
1000207

  • Fixed examination/treatment room light
Exam Light, 32" LUMERUS LED Back Mtd, Std Plug
Medical Technology Industries, Inc.
1000200
In Commercial Distribution

  • 10840118404836 ()
1000200

  • Fixed examination/treatment room light
Exam Light, 32" LUMERUS LED Back Mtd, IEC 320 Plug
Medical Technology Industries, Inc.
1000205
In Commercial Distribution

  • 10840118404829 ()
1000205

  • Fixed examination/treatment room light
830 Procedure Chair, Swivel Base, 100-240V
Medical Technology Industries, Inc.
830-002-80
In Commercial Distribution

  • 10840118400524 ()
830-002-80

  • General examination/treatment chair, electric
829 Procedure Chair, Std Base, 100-240V
Medical Technology Industries, Inc.
829-001-80
In Commercial Distribution

  • 10840118400487 ()
829-001-80

  • General examination/treatment chair, electric
829 Procedure Chair, Mobile Base, 100-240V
Medical Technology Industries, Inc.
829-003-22
In Commercial Distribution

  • 10840118400470 ()
829-003-22

  • General examination/treatment chair, electric
705 Contour Seat Consult/Exam Chair, 230V
Medical Technology Industries, Inc.
7000029
In Commercial Distribution

  • 10840118400425 ()
7000029

  • Dental chair, electric
705 Contour Seat Consult/Exam Chair, 115V
Medical Technology Industries, Inc.
7000028
In Commercial Distribution

  • 10840118400418 ()
7000028

  • Dental chair, electric
550 Procedure Chair, Swivel Base, 100-240V
Medical Technology Industries, Inc.
550-002-80
In Commercial Distribution

  • 10840118400401 ()
550-002-80

  • General examination/treatment chair, electric
550 Procedure Chair, Std Base, 100-240V
Medical Technology Industries, Inc.
550-001-80
In Commercial Distribution

  • 10840118400395 ()
550-001-80

  • General examination/treatment chair, electric
550 Procedure Chair, Mobile Base, 100-240V
Medical Technology Industries, Inc.
550-003-22
In Commercial Distribution

  • 10840118400388 ()
550-003-22

  • General examination/treatment chair, electric
527W Bariatric Exam/Procedure Chair, 230V
Medical Technology Industries, Inc.
5270006
In Commercial Distribution

  • 10840118400371 ()
5270006

  • General examination/treatment chair, electric
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