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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Medical Oxygen Sensor, SERV02 GP
CITY TECHNOLOGY LIMITED
6600-1278-600
In Commercial Distribution

  • B404660012786000 ()


  • Respiratory oxygen sensor
JONES MEDICAL 3L SYRINGE 5570
HANS RUDOLPH, INC.
5570
In Commercial Distribution

  • 00817136024493 ()
113864

  • Spirometer/pulmonary function analyser syringe
Precision Medical BlenderBuddy with Flowmeter
MAXTEC, LLC
BlenderBuddy
In Commercial Distribution

  • 00817770022350 ()
R219P20-001

  • Medical gas flowmeter, Thorpe tube
MAX-250+ Oxygen Sensor Drive Medical
MAXTEC, LLC
R125P02-014
Not in Commercial Distribution

  • 00817770021247 ()


  • Respiratory oxygen sensor
ANALYZER, MAX02+ MEDICAL AE INTERNATIONAL
MAXTEC, LLC
R217P72-003
In Commercial Distribution

  • 00817770020684 ()


  • Respiratory oxygen monitor, line-powered
CF MEDICAL INTELLIGENCE SECUREFIT BAR
Bionix Radiation Therapy, LLC
UTRT-7019
Not in Commercial Distribution

  • 00817740021178 ()
UTRT-7019

  • Vacuum-mould patient positioning system
Adhesive Medical Fields with Fenestration
Industrias Goes Mx, S.A. de C.V.
CE-O-00001
In Commercial Distribution

  • G397CDGI0032 ()
  • GI0032 ()
CDGI0032

  • Patient surgical drape, single-use
Medical ID Bracelets, Pediatric, White
ENDURE INDUSTRIES
IDPWA8
In Commercial Distribution

  • 00840118614719 ()
  • 00840118614702 ()
  • 00840118614726 ()
IDPWA8

  • Patient identification band
Medical ID Bracelets, Pediatric, Pink
ENDURE INDUSTRIES
IDPPA8
In Commercial Distribution

  • 00840118614689 ()
  • 00840118614672 ()
  • 00840118614696 ()
IDPPA8

  • Patient identification band
Medical ID Bracelets, Pediatric, Blue
ENDURE INDUSTRIES
IDPBA8
In Commercial Distribution

  • 00840118614658 ()
  • 00840118614641 ()
  • 00840118614665 ()
IDPBA8

  • Patient identification band
Medical ID Bracelets, Adult, White
ENDURE INDUSTRIES
IDAWA8
In Commercial Distribution

  • 00840118614627 ()
  • 00840118614610 ()
  • 00840118614634 ()
IDAWA8

  • Patient identification band
Medical ID Bracelets, Adult, Pink
ENDURE INDUSTRIES
IDAPA8
In Commercial Distribution

  • 00840118614597 ()
  • 00840118614580 ()
  • 00840118614603 ()
IDAPA8

  • Patient identification band
Medical ID Bracelets, Adult, Blue
ENDURE INDUSTRIES
IDABA8
In Commercial Distribution

  • 00840118614566 ()
  • 00840118614559 ()
  • 00840118614573 ()
IDABA8

  • Patient identification band
Medical Power Cable, 12.0 ft
ALPHATEC SPINE, INC.
525-412-008
In Commercial Distribution

  • 00190376635583 ()


  • Neurological stereotactic surgery system
MD CPN 6.96 MEDICAL DEVICE
GE HEALTHCARE
PERINATAL6.96
Not in Commercial Distribution

  • 00840682102681 ()


  • Patient health record information system
AW Server 3.2 Medical Device
GE MEDICAL SYSTEMS
3.2
In Commercial Distribution

  • 00840682102384 ()


  • Radiological PACS software
Reliable Medical 2 x 2
COMPASS HEALTH BRANDS CORP.
EF2020BC2-TU
Not in Commercial Distribution

  • 40092237616916 ()
  • 50092237616913 ()
  • 00009223761699 ()
  • 01092237616917 ()


  • Transcutaneous electrical stimulation electrode, single-use
Tip, Modular Stem, Wright Medical
Shukla Medical
120-06
In Commercial Distribution

  • B756120060 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
27" SC27810 4K Medical monitor
LINDEN GROUP CORPORATION, THE
SC27810
In Commercial Distribution

  • 00819761022929 ()


  • Image display unit, colour
HB5MW0-C110 CHAIR AND TABEL, MEDICAL
Comfytopia, Inc.
HB5MW0-C110
In Commercial Distribution

  • 00819567012285 ()


  • Shower seat, non-powered
Long Term Medical Supply, Sportneb
Drive Devilbiss Healthcare
3050-2-LTMS
Not in Commercial Distribution

  • 10822383295326 ()
  • 00822383295329 ()


  • Benchtop nebulizer, non-heated
PACK,CATHETER,VA MEDICAL CTR
MEDLINE INDUSTRIES, INC.
DYK1097006C
In Commercial Distribution

  • 10884389687710 ()
DYK1097006C

  • General surgical procedure kit, non-medicated, reusable
KIT,ENDO,BARBOUR MEDICAL CTR
MEDLINE INDUSTRIES, INC.
DYK1097615E
In Commercial Distribution

  • 10884389749753 ()
DYK1097615E

  • General surgical procedure kit, non-medicated, reusable
ENDO KIT,FOREST PARK MEDICAL
MEDLINE INDUSTRIES, INC.
DYK1284217E
In Commercial Distribution

  • 40884389907253 ()
  • 10884389907252 ()
DYK1284217E

  • Endoscopy preparation kit
HOSE ASSEMBLY, MEDICAL AIR, YELLOW
Carefusion Corporation
463606
Not in Commercial Distribution

  • 10846446015355 ()
463606

  • Stationary electric high-frequency ventilator
SIGNA Prime System Medical Device
GE Medical Systems (Tianjin) Co., Ltd.
SIGNA Prime
In Commercial Distribution

  • 00840682146302 ()


  • Full-body MRI system, superconducting magnet
Software Medical Device INW V7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682145756 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
MD CPN 6.97 MEDICAL DEVICE
GE HEALTHCARE
Perinatal6.97
Not in Commercial Distribution

  • 00840682123785 ()


  • Patient health record information system
Discovery RT designated medical device
Hangwei GE Medical Systems Co., Ltd.
RT
In Commercial Distribution

  • 00840682118699 ()


  • Full-body CT system
SIGNA Creator System Medical Device
GE Medical Systems (Tianjin) Co., Ltd.
SIGNA Creator
In Commercial Distribution

  • 00840682113786 ()


  • Full-body MRI system, superconducting magnet
SIGNA Explorer System Medical Device
GE Medical Systems (Tianjin) Co., Ltd.
SIGNA Explorer
In Commercial Distribution

  • 00840682113762 ()


  • Full-body MRI system, superconducting magnet
.5MM MEDICAL COAT APRON WHITE
Palmero Healthcare LLC
34MWHITE
In Commercial Distribution

  • 00840415111454 ()
34MWHITE

  • Radiation shielding apron
.5MM MEDICAL COAT APRON TEAL
Palmero Healthcare LLC
34MTEAL
In Commercial Distribution

  • 00840415111447 ()
34MTEAL

  • Radiation shielding apron
.5MM MEDICAL COAT APRON TAUPE
Palmero Healthcare LLC
34MTAUPE
In Commercial Distribution

  • 00840415111430 ()
34MTAUPE

  • Radiation shielding apron
.5MM MEDICAL COAT APRON MAUVE
Palmero Healthcare LLC
34MMAUVE
In Commercial Distribution

  • 00840415111393 ()
34MMAUVE

  • Radiation shielding apron
.5MM MEDICAL COAT APRON GREY
Palmero Healthcare LLC
34MGREY
In Commercial Distribution

  • 00840415111379 ()
34MGREY

  • Radiation shielding apron
.5MM MEDICAL COAT APRON GREEN
Palmero Healthcare LLC
34MGREEN
In Commercial Distribution

  • 00840415111362 ()
34MGREEN

  • Radiation shielding apron
.5MM MEDICAL COAT APRON BLUE
Palmero Healthcare LLC
34MBLUE
In Commercial Distribution

  • 00840415111331 ()
34MBLUE

  • Radiation shielding apron
.5MM MEDICAL COAT APRON BLACK
Palmero Healthcare LLC
34MBLACK
In Commercial Distribution

  • 00840415111324 ()
34MBLACK

  • Radiation shielding apron
.5MM MEDICAL COAT APRON BEIGE
Palmero Healthcare LLC
34MBEIGE
In Commercial Distribution

  • 00840415111317 ()
34MBEIGE

  • Radiation shielding apron
Medical Gas Dryer Vero Biotech
PERMA PURE LLC
ME Series
In Commercial Distribution

  • 10840106905536 ()
  • 00840106905539 ()
  • 20840106905533 ()
  • 30840106905530 ()
  • 40840106905537 ()
ME-070-03-48

  • Gas-sampling/monitoring respiratory tubing, single-use
Medical thermometer with rigid tip
Masena Invest B.V.
DT-R1221B-US-WG
In Commercial Distribution

  • 08719481721695 ()


  • Intermittent electronic patient thermometer
Medical thermometer with flexible tip
Masena Invest B.V.
DT-R1221A-US-WG
In Commercial Distribution

  • 08719481721671 ()


  • Intermittent electronic patient thermometer
Medical thermometer with rigid tip
Masena Invest B.V.
DT-K117B-US-WG
In Commercial Distribution

  • 08719481721657 ()


  • Intermittent electronic patient thermometer
Medical thermometer with flexible tip
Masena Invest B.V.
DT-K117A-US-WG
In Commercial Distribution

  • 08719481721633 ()


  • Intermittent electronic patient thermometer
Kizuna System Medical Device Assembly
GE Medical Systems (Tianjin) Co., Ltd.
SIGNA Voyager
In Commercial Distribution

  • 00840682108607 ()
M70012TB

  • Full-body MRI system, superconducting magnet
Optima CT520 designated medical device
Hangwei GE Medical Systems Co., Ltd.
CT520
In Commercial Distribution

  • 00840682102568 ()


  • Full-body CT system
Genie Medical CI Fitting Software
NEURELEC
178371
In Commercial Distribution

  • 03663227001532 ()


  • Hearing aid/implant system programming interface unit
BPSK SHAWNEE MISSION MEDICAL CENTER
B. BRAUN MEDICAL INC.
570291
In Commercial Distribution

  • 04046955114337 ()
  • 04046955114320 ()
570291

  • Peripheral anaesthesia catheter set, medicated
CESK-SD DCH REGIONAL MEDICAL CENTER
B. BRAUN MEDICAL INC.
552137
In Commercial Distribution

  • 04046955125067 ()
  • 04046955125050 ()

  • Gauge epidural needle : 20
552137

  • Epidural anaesthesia set, medicated
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