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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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PROGAV 2.0 COMPASS
Christoph Miethke GmbH & Co. KG
FX401T
In Commercial Distribution

  • 04041906140830 ()
FX401T

  • Cerebrospinal fluid shunt valve programmer
"Sunlight MiniOmni: The Sunlight MiniOmni Ultrasound Bone Sonometer is a non-invasive ultrasound device capable of measuring bone speed of sound (SOS) at one or more skeletal sites. Sunlight MiniOmni Ultrasound Bone Sonometer is a modified version of company's well- established Sunlight Omnisense systems*. Sunlight MiniOmni is based on the Sunlight Omnipath™ technology already CE marked and approved by the FDA (PMA). It is comprised of a Main Unit and the same hand held probes as used with other BeamMed's Bone Sonometers, each designed to measure SOS at one or more specific skeletal sites. The basic system is offered with one probe, capable of measuring SOS of the distal one-third radius and the mid-shaft tibia. Reference databases are provided for measurements at each of the skeletal sites, Sunlight MiniOmni measures SOS utilizing a technology based on well- established laws of physics applied to the transmission of signals along the bone. The measurements are performed while the subject and the operator are comfortably seated. Results are expressed in meters per second (m/sec), reflecting the upper 95th percentile of the sorted SOS values. Sunlight MiniOmni reports the bone SOS, together with the Z-score (units of standard deviations relative to age and gender matched population reference values), for adults also as a T-score values (units of standard deviations relative to population reference values of healthy young adults), and patient risk assessment, computed using the patient's SOS value and a reference database. For any two measured skeletal sites, Sunlight No calibration is required. Daily system verification is accomplished using the System Quality Verification (SQV) phantom supplied with the device. Probes: MiniOmni is a multiple skeletal sites. The probes designed to support measurement at the following areas: • CM probes - used for bone strength assessment at the radius and tibia • CS probe - used for bone strength assessment at the phalanx • CR
BEAMMED LTD
Sunlight MiniOmni Ultrasound Bone Sonometer
In Commercial Distribution

  • 07290012704109 ()


  • Bone absorptiometric ultrasound system
Site~Rite 8 Ultrasound System Console (Remanufactured)
Bard Access Systems, Inc.
9770600Y
In Commercial Distribution

  • 00801741138287 ()
9770600Y

  • Ultrasound imaging system operator console
CODMAN CERTAS X-Ray Overlay Tool
Medos International Sàrl
82-8859
Not in Commercial Distribution

  • 20886704078651 ()
  • 10886704078654 ()
828859

  • Cerebrospinal fluid shunt valve programmer
"Omnisense 7000: The Sunlight Omnisense Ultrasound Bone Sonometer is a non-invasive ultrasound device capable of measuring bone speed of sound (SOS) at one or more skeletal sites. It is comprised of a Main Unit and small hand held probes, each designed to measure SOS at one or more specific skeletal sites. The basic system is offered with one probe, capable of measuring SOS of the distal one-third radius and the mid-shaft tibia. Reference databases are provided for measurements at each of the skeletal sites. Omnisense measures SOS utilizing a technology based on well established laws of physics applied to the transmission of signals along the bone. The measurements are performed while the subject and the operator are comfortably seated. Results are expressed in meters per second (m/sec), reflecting the upper 95th percentile of the sorted SOS values. Omnisense reports the bone SOS, together with the T-score (units of standard deviations relative to population reference values of healthy young adults), Z-score values (units of standard deviations relative to age and gender matched population reference values), and patient risk assessment, computed using the patient's SOS value and a reference database. For any two measured skeletal sites, Omnisense may report the Osteoporosis, Risk Index (ORI™), which combines the individual results into a single clinical index. No calibration is required. Daily system verification is accomplished using the System Quality Verification (SQV) phantom supplied with the device. Probes: Omnisense is a multiple skeletal sites. The probes designed to support measurement at the following areas: • CM probe - used for bone strength assessment at the radius and tibia • CS probe - used for bone strength assessment at the phalanx • CR probe - used for bone strength assessment at the metatarsal The probes can be supplied with Omnisense 7000 and/or Omnisense 8000. Omnisense models: S – Adult application P – Pediatric application Premier - Premature
BEAMMED LTD
OMNISENSE 7000 ULTRASOUND BONE SONOMETER
Not in Commercial Distribution

  • 07299012704119 ()


  • Bone absorptiometric ultrasound system
Medical parallel transport bed
Xiamen Weiyou Intelligent Technology Co.,Ltd
XW-PTB-8S
In Commercial Distribution

  • 06971234479655 ()


  • Bed transporter
CARD 45807 SMART STRATA
MEDTRONIC PS MEDICAL, INC.
45807
In Commercial Distribution

  • 00763000351410 ()


  • Cerebrospinal fluid shunt valve programmer
TOOL 45809 STRATAVARIUS ADJUSTMENT
MEDTRONIC PS MEDICAL, INC.
45809
In Commercial Distribution

  • 00763000292553 ()


  • Cerebrospinal fluid shunt valve programmer
KIT 45806 STRATA VARIUS
MEDTRONIC PS MEDICAL, INC.
45806
In Commercial Distribution

  • 00763000292546 ()


  • Cerebrospinal fluid shunt valve programmer
KIT 45805 FP STRATA 2 ADJUSTMENT
MEDTRONIC PS MEDICAL, INC.
45805
In Commercial Distribution

  • 00763000281274 ()


  • Cerebrospinal fluid shunt valve programmer
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