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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J.MORITA MFG.CORP.
DP-ZX
In Commercial Distribution

  • 04548213013227 ()


  • Endodontic enlarger, reusable
Apex Locator
J.MORITA MFG.CORP.
RCM-7
In Commercial Distribution

  • 00887919758013 ()
5025412U0

  • Endodontic apex locator
10cm iQ Broad Knife
STRYKER CORPORATION
550025B110
In Commercial Distribution

  • 07613327548105 ()
  • 37613327548106 ()
5500-25B-110

  • Hard-tissue ultrasonic surgical system handpiece tip
MPM Triple Helix Collagen Wound Drsg 7X7 Sterile. is an advance wound care device 100% bovine type 1 collagen. MPM collagen is a biogradable pad to absorbe exudate Package configuration: 1 dressing per SBS; 10 SBS per case
Mpm Medical, LLC
2
In Commercial Distribution

  • 00366977377775 ()
MP00377

  • Animal-derived wound matrix dressing
Intra-Compartmental Pressure Monitor System
STRYKER CORPORATION
0295006000
In Commercial Distribution

  • 34546540052323 ()
  • 04546540052322 ()
0295006000

  • Compartmental-pressure monitoring system, single-use
Pressure Monitor
STRYKER CORPORATION
0295001000
In Commercial Distribution

  • 04546540052285 ()
0295001000

  • Compartmental-pressure monitoring system, reusable
The PulStar Spine Mobilization Device is intended for use by chiropractors, physical therapists and physicians for mobilization of the spine. The device consists of a hand-held impulse head attached to an electronic control module. The control module is connected to an Apple computer through a USB cable. Appropriate software is used to display the results of tissue compliance measurements. Intended Use and operation: Intended use of the PulStar is for the treatment of musculoskeletal pain due to joint subluxation, restricted joint mobility, myofacial spasm and ligamentous strain. The clinician uses a hand held impulse head to test the stiffness of the patient’s spine at each vertebral level, the results of this procedure are recorded in the patient file in a computer database and displayed on the computer screen. The clinician then decides where therapy is needed and applies multiple impulses with the impulse head to those areas of the body of the patient with the intent of reducing spinal stiffness. After treatment, the clinician repeats the initial test of the patient’s spine to document changes in stiffness effected by the therapy.
Sense Technology, Inc.
G3
In Commercial Distribution

  • 10855341008003 ()
  • 00855341008006 ()


  • Joint/spinal manipulator, electronic
The Compartmental Compressibility Monitoring System (CPMX1) is a point-of-care device for non-invasive, real-time, and intermittent monitoring of relative compartment compressibility. The CPMX1 System includes the CP Probe, a handheld and reusable probe combining a flat linear ultrasound array with an integrated pressure sensor to obtain cross-section ultrasound views of the compartment of interest. The CP Probe works in conjunction with the CPMX1 Software, which provides a surrogate metric of the compartment's compressibility in one ultrasound image plane only, using a linear measurement of distance between two points of the compartment, as a function of applied external pressure. Based on this measurement, a relative compartment compressibility value is calculated and displayed on-screen as the CP Value.
Compremium AG
1
In Commercial Distribution

  • G247CPMX10 ()
  • G247CPMX12 ()


  • Compartmental-pressure monitoring system, reusable
Hard Tissue Curette Handpiece without Tip, 25 kHz
STRYKER MEDTECH K.K.
5450811000
In Commercial Distribution

  • 07613327291957 ()
5450-811-000

  • Soft-tissue ultrasonic surgical system handpiece, reusable
Foot Switch
STRYKER MEDTECH K.K.
5450850007
In Commercial Distribution

  • 07613327291940 ()
5450-850-007

  • Foot-switch, electrical
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