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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MEGA-AMZ-TAMP-1 - FLO Organic Cotton App Tampons Regular Pack (80 Tampons)
HERE WE FLO LTD
MEGA-AMZ-TAMP-1
In Commercial Distribution

  • 05060630101497 ()


  • Menstrual tampon, unscented
Meridian Medical APP System - adjustable pump and single layer pad
COMPASS HEALTH BRANDS CORP.
MER-APP2
In Commercial Distribution

  • 00815067043521 ()


  • Alternating-pressure bed mattress overlay system
Cora Tampons, DTC, App. Light 5/Reg. 6/Super 5
Cora
02Tampons-105
In Commercial Distribution

  • 00850373007041 ()
  • 00810042480568 ()


  • Menstrual tampon, unscented
SPRAY SET ENDOSCOPIC APP. 5MM, 40 CM, 1:1 RATIO
Micromedics, Inc.
SA-3655
In Commercial Distribution

  • 00815634020085 ()
  • 10815634020082 ()
  • 20815634020089 ()


  • Open-surgery adhesive/sealant applicator, dual-channel
For the wireless mode version of the subject device, combined with an application installed on a tablet that can be used in a home environment, the content of the SPM01K4 convenience kit is: 1 electrostimulator SPM01M1 configuration; electrodes; protective skin, and 1 tablet with the MySPM@Home mobile application (SPM01A2).
NCS LAB SRL
SPM01K4
In Commercial Distribution

  • 08051122040971 ()
SPM01K4

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
267363
In Commercial Distribution

  • 03661489673634 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
NXSTAGE MEDICAL, INC.
NX1379
Not in Commercial Distribution

  • M535NX1225NX1379 ()


  • Medical equipment clinical data interfacing software
No Description
BIOTRONIK SE & Co. KG
493241
In Commercial Distribution

  • 04035479188733 ()
493241

  • Implantable electrical stimulation device management software
No Description
BIOTRONIK SE & Co. KG
487878
In Commercial Distribution

  • 04035479185817 ()
487878

  • Implantable electrical stimulation device management software
reSET-O® Mobile Application running on Android. reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008125 ()


  • Mental health/function therapeutic software, screen-viewed
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