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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PERIODONTAL SCALER DOUBLE ENDED TOWNER /JACQUETTE, H5/33, HOLLOW HANDLE
Helmut Zepf Medizintechnik GmbH
24.565.33
In Commercial Distribution

  • EZPF24565330 ()
24.565.33

  • Periodontal curette
30GR ANGLED PAD ABUT., H5 MM PREMIUM-KOHNO D.5.00 MM
SWEDEN & MARTINA SPA
A-PAD-AA500-305
In Commercial Distribution

  • D7700871873 ()
A-PAD-AA500-305

  • Dental implant suprastructure, permanent, preformed
17GR ANGLED PAD ABUT., H5 MM PREMIUM-KOHNO D.5.00 MM
SWEDEN & MARTINA SPA
A-PAD-AA500-175
In Commercial Distribution

  • D7700871853 ()
A-PAD-AA500-175

  • Dental implant suprastructure, permanent, preformed
30GR ANGLED PAD ABUT., H5 MM PREMIUM-KOHNO D.4.25 MM
SWEDEN & MARTINA SPA
A-PAD-AA425-305
In Commercial Distribution

  • D7700871833 ()
A-PAD-AA425-305

  • Dental implant suprastructure, permanent, preformed
17GR ANGLED PAD ABUT., H5 MM PREMIUM-KOHNO D.4.25 MM
SWEDEN & MARTINA SPA
A-PAD-AA425-175
In Commercial Distribution

  • D7700871813 ()
A-PAD-AA425-175

  • Dental implant suprastructure, permanent, preformed
Clinical decision support software indicated for use by licensed clinicians to inform the detection of disease utilizing an iOS client.
AMBIENT CLINICAL ANALYTICS, INC.
1.0
In Commercial Distribution

  • 00850893007033 ()


  • Clinical management support software
No Description
Sugarmate, LLC
1007228
In Commercial Distribution

  • 00850018992435 ()


  • Self-care monitoring/reporting software
No Description
BIOSERENITY MEDICAL DEVICES GROUP
5100-00012
Not in Commercial Distribution

  • 03615220002610 ()


  • Electroencephalographic monitoring system
Mobile Application Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52603
In Commercial Distribution

  • 09008737526030 ()


  • Audiometric/hearing device software
No Description
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838103405 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
IV START KIT W/CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2325
In Commercial Distribution

  • 20193489194811 ()
  • 10193489194814 ()
DYNDV2325

  • Peripheral intravenous catheterization support kit
MAJ-1352 BALLOON APP. FOR EBUS BRONCHSCP
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1352
In Commercial Distribution

  • 04953170355981 ()


  • Surgical instrument assist arm system, manually-adjusted
IV START KIT W/CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYND74260
In Commercial Distribution

  • 10080196992980 ()
  • 40080196992981 ()
DYND74260

  • General surgical procedure kit, non-medicated, single-use
PAD,REPLACEMENT,APP,W/FLAPS,AIRONE
MEDLINE INDUSTRIES, INC.
MSC80710
In Commercial Distribution

  • 10080196669943 ()
MSC80710

  • Alternating-pressure inflator
Bluetooth Basal Thermometer with Ovy App
BEURER NORTH AMERICA, L.P.
OT30
In Commercial Distribution

  • 00850003500560 ()
791.77

  • Thermometric fertility analyser
SW APP A610 ACTIVA CLINICIAN DBS
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00643169855649 ()


  • Multiple active implantable device programmer
SW APP A521 GU PATIENT EVALUATION
MEDTRONIC, INC.
A521
In Commercial Distribution

  • 00643169834330 ()


  • Wearable peripheral nerve electrical stimulator programmer
SW APP A511 GU CLINICIAN EVALUATION
MEDTRONIC, INC.
A511
In Commercial Distribution

  • 00643169834323 ()


  • Wearable peripheral nerve electrical stimulator programmer
SW D00U002 CARELINK SMARTSYNC PSA APP
MEDTRONIC, INC.
D00U002
In Commercial Distribution

  • 00643169833753 ()


  • Implantable cardiac device management application software
SW APP A902 PATIENT DATA SERVICES
MEDTRONIC, INC.
A902
In Commercial Distribution

  • 00643169738065 ()


  • Multiple active implantable device programmer
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