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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RGBASIN 5500CC EPP SUSTAIN KIT
Cardinal Health 200, LLC
13752-727
In Commercial Distribution

  • 50888439980996 ()
  • 10888439980998 ()
13752-727

  • General surgical procedure kit, non-medicated, single-use
NDL CNTR 30CT EPP SUSTAIN KIT
Cardinal Health 200, LLC
21000-030
In Commercial Distribution

  • 50888439981030 ()
  • 10888439981032 ()
21000-030

  • General surgical procedure kit, non-medicated, single-use
EM BASIN 700CC EPP SUSTAIN KIT
Cardinal Health 200, LLC
13752-725
In Commercial Distribution

  • 50888439981023 ()
  • 10888439981025 ()
13752-725

  • General surgical procedure kit, non-medicated, single-use
SPNG BOWL 32OZ EPP SUSTAIN KIT
Cardinal Health 200, LLC
13752-726
In Commercial Distribution

  • 50888439981016 ()
  • 10888439981018 ()
13752-726

  • General surgical procedure kit, non-medicated, single-use
NDL CNTR 40CT EPP SUSTAIN KIT
Cardinal Health 200, LLC
21000-040
In Commercial Distribution

  • 50888439981009 ()
  • 10888439981001 ()
21000-040

  • General surgical procedure kit, non-medicated, single-use
Microdermabrasion Machine
Innovative Med
19-2000
In Commercial Distribution

  • 00851314007298 ()


  • Dermabrasion brush, manual
Suction Machine
COMPASS HEALTH BRANDS CORP.
7000
Not in Commercial Distribution

  • 00841447104261 ()
7000

  • Emergency airway clearance suction pump, electric
ACTIVE MACHINE CORD W/BOVIE MACHINE PLUG
GRACE MANUFACTURING, INC.
C1320-01
In Commercial Distribution

  • 10801334013943 ()

  • Length: 8 Feet


  • Electrical-only medical device connection cable, reprocessed
Cocoon Warming Machine
CARE ESSENTIALS PTY LTD
CWS 4000
In Commercial Distribution

  • 09332017000553 ()
CWS 4000

  • Circulating-air whole-body heating system control unit
Cocoon Warming Machine
CARE ESSENTIALS PTY LTD
CWS 5000
In Commercial Distribution

  • 09332017002007 ()
CWS 5000

  • Circulating-air whole-body heating system control unit
Machine Screwdriver abutment
Cochlear Bone Anchored Solutions AB
90397
In Commercial Distribution

  • 09321502034579 ()
90397

  • Surgical screwdriver, reusable
Portable Suction Machine
SUNSET HEALTHCARE SOLUTIONS, INC.
SU100DC
In Commercial Distribution

  • 00848530088965 ()
  • 10848530088962 ()
SU100DC

  • General-purpose suction system, line-powered
Air purification machine
AEROBIOTIX, INC.
HUAIRS-MD
In Commercial Distribution

  • 00852348007995 ()


  • Surgical laminar airflow unit
Air purification machine
AEROBIOTIX, INC.
HUAIRS+
In Commercial Distribution

  • 00852348007988 ()


  • Surgical laminar airflow unit
Air purification machine
AEROBIOTIX, INC.
SENSE
In Commercial Distribution

  • 00852348007889 ()


  • Surgical laminar airflow unit
Air purification machine
AEROBIOTIX, INC.
AeroCure-MD
In Commercial Distribution

  • 00852348007773 ()


  • Surgical laminar airflow unit
Air purification machine
AEROBIOTIX, INC.
AeroCure Vac
In Commercial Distribution

  • 00852348007551 ()


  • Surgical laminar airflow unit
Air purification machine
AEROBIOTIX, INC.
AeroCure VAC+
In Commercial Distribution

  • 00852348007155 ()


  • Surgical laminar airflow unit
Abutment inserter, machine
Oticon Medical AB
M51695
In Commercial Distribution

  • 05712149005895 ()
M51695

  • Surgical screwdriver, reusable
Screwdriver, machine, 35mm
Oticon Medical AB
M50384
In Commercial Distribution

  • 05712149000562 ()
M50384

  • Surgical screwdriver, reusable
Therapy Machine (Non-App)
NUVOMED, INC.
INV00564
In Commercial Distribution

  • 00859811008510 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Therapy Machine (Non-App)
NUVOMED, INC.
TTM-6/0740
In Commercial Distribution

  • 00859811007407 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Genius Anesthetic Machine
SPACELABS HEALTHCARE (WASHINGTON), INC
Genius
In Commercial Distribution

  • 10841522100048 ()
Genius

  • Anaesthesia unit, mobile
Focus Anesthetic Machine
SPACELABS HEALTHCARE (WASHINGTON), INC
Focus
In Commercial Distribution

  • 10841522100031 ()
Focus

  • Anaesthesia unit, mobile
Roscoe Suction Machine
COMPASS HEALTH BRANDS CORP.
50004
In Commercial Distribution

  • 20092237603370 ()
  • 00092237603376 ()


  • Emergency airway clearance suction system, electric
Dialyzer reprocessing machine.
Angelini Pharma Inc.
21.1
In Commercial Distribution

  • 00898021000037 ()
MAKY21.1

  • Haemodialysis dialyser reprocessing system
EVERCLEAN MAINTENANCE MACHINE
Peter Brasseler Holdings, LLC
5028208U0
In Commercial Distribution

  • 00887919871873 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic
Ice Therapy Machine
VIVE HEALTH LLC
RHB1049GRY
In Commercial Distribution

  • 10818323022251 ()
  • 00818323022254 ()


  • Circulating-fluid localized thermal/compression therapy system control unit
Portable Suction Machine
Drive Devilbiss Healthcare
18615
Not in Commercial Distribution

  • 10822383509140 ()
  • 00822383509143 ()


  • Vacuum suction regulator/regulation set, thoracic
Plus Suction Machine
Drive Devilbiss Healthcare
18610
Not in Commercial Distribution

  • 10822383509133 ()
  • 00822383509136 ()


  • Vacuum suction regulator/regulation set, thoracic
Screwdriver Machine Slot
Nobel Biocare AB
2430
In Commercial Distribution

  • 07332747023244 ()
2430

  • Surgical screwdriver, reusable
Ice Machine Therapy
VIVE HEALTH LLC
RHB1049
In Commercial Distribution

  • 10810041981537 ()
  • 00810041981530 ()


  • Cold therapy pack chilling unit
Vacu-Aide Suction Machine
DEVILBISS HEALTHCARE LLC
7325P-D-EXF
In Commercial Distribution

  • 00885304032571 ()
7325P-D-EXF

  • Airway suction catheter
Vacu-Aide Suction Machine
DEVILBISS HEALTHCARE LLC
7325D-D-EXF
In Commercial Distribution

  • 00885304032557 ()
7325D-D-EXF

  • Airway suction catheter
Machine Bag, 5"x5"
Dynarex Corporation
2162
In Commercial Distribution

  • 00616784216232 ()
  • 00616784216225 ()
  • 00616784216218 ()


  • Medical equipment/instrument drape, single-use
Indications for FH: The Apheresis Machine KANEKA MA-03 is components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma. Indications for FSGS: The Apheresis Machine KANEKA MA-03 is components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
KANEKA MA-03
In Commercial Distribution

  • 04987671040374 ()


  • Apheresis system
Machine Screwdriver 25mm UniGrip
Cochlear Bone Anchored Solutions AB
90381
In Commercial Distribution

  • 09321502016513 ()

  • Length: 25 Millimeter
  • 25 mm long screwdriver
90381

  • Surgical screwdriver, reusable
Machine Screwdriver 20mm UniGrip
Cochlear Bone Anchored Solutions AB
90380
In Commercial Distribution

  • 09321502040082 ()

  • 20 mm screwdriver
  • Length: 20 Millimeter
90380

  • Surgical screwdriver, reusable
iGO Screwdriver, Machine 32mm
Neoss AB
51184
In Commercial Distribution

  • 05060440333583 ()
51184

  • Surgical screwdriver, reusable
iGO Screwdriver, Machine 22mm
Neoss AB
51183
In Commercial Distribution

  • 05060440333576 ()
51183

  • Surgical screwdriver, reusable
Neo Screwdriver, Machine 32mm
Neoss AB
51140
In Commercial Distribution

  • 05060440332609 ()
51140

  • Surgical screwdriver, reusable
Neo Screwdriver, Machine 22mm
Neoss AB
51139
In Commercial Distribution

  • 05060440332593 ()
51139

  • Surgical screwdriver, reusable
Portable Suction Machine AC
SUNSET HEALTHCARE SOLUTIONS, INC.
SU100AC
In Commercial Distribution

  • 00848530091378 ()


  • Emergency airway clearance suction pump, electric
MACHINE GRAF PROCESSING -LF
MEDLINE INDUSTRIES, INC.
DYNJ9985295C
In Commercial Distribution

  • 40889942373858 ()
  • 10889942373857 ()
DYNJ9985295C

  • General surgical procedure kit, non-medicated, reusable
Square fit connection, machine
Oticon Medical AB
M50386
In Commercial Distribution

  • 05712149000586 ()
M50386

  • Surgical screwdriver, reusable
ARKON, ANESTHESIA DELIVERY MACHINE
SPACELABS HEALTHCARE (WASHINGTON), INC
ARKON
Not in Commercial Distribution

  • 10841522100017 ()
ARKON

  • Anaesthesia unit, mobile
RADIOLUCENT CLAMP BASE MACHINE
INTEGRA LIFESCIENCES CORPORATION
437C1073
In Commercial Distribution

  • M268437C10731 ()
  • 10381780255239 ()


  • Skull clamp
Heavy Duty Suction Machine
Drive Devilbiss Healthcare
18600
In Commercial Distribution

  • 00822383111377 ()


  • Airway suction catheter
ACTIVE BOVIE MACHINE PLUG
GRACE MANUFACTURING, INC.
C9019-00
In Commercial Distribution

  • 10801334000332 ()
C9019-00

  • Electrosurgical/ultrasonic surgical system tester interface
SLUSH MACHINE COVER, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426118347 ()
  • 00748426118342 ()


  • General-purpose bowl, single-use
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