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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3 SERIES MULTI MACHINE PC 311/350-24/24 208-240V 60HZ
DAAVLIN DISTRIBUTING CO., THE
3 SERIES MULTI MACHINE PC
Not in Commercial Distribution

  • B280861PH2424MMPC60 ()
861PH2424MMPC6

  • Ultraviolet phototherapy unit, professional
M SERIES MULTI MACHINE PC 311/350-4/6 110-120V 60HZ
DAAVLIN DISTRIBUTING CO., THE
M SERIES MULTI MACHINE
Not in Commercial Distribution

  • B280803MI0604MMPC60 ()
803MI0604MMPC6

  • Ultraviolet phototherapy unit, professional
M SERIES MULTI MACHINE PC 311/350-4/6 110-120V 60HZ
DAAVLIN DISTRIBUTING CO., THE
M SERIES MULTI MACHINE
Not in Commercial Distribution

  • B280801MI0604MMPC60 ()
801MI0604MMPC6

  • Ultraviolet phototherapy unit, professional
Foredom powered 66" flexible shaft machine, includes Hand-held Massager Handpiece.
Foredom Electric Co
K.500L
In Commercial Distribution

  • 00098666032336 ()


  • Hand-held electric massager
Foredom powered 39" flexible shaft machine, includes Hand-held Massager Handpiece.
Foredom Electric Co
K.500
In Commercial Distribution

  • 00098666032305 ()


  • Hand-held electric massager
Hand-held Massager Handpiece used with Foredom powered flexible shaft machine.
Foredom Electric Co
H.60
In Commercial Distribution

  • 00098666028612 ()


  • Hand-held electric massager
Medfix® Adapter For Drilling Machine 1/4",Triangular End
MEDFIX INTERNATIONAL, LLC
MF750-3003
In Commercial Distribution

  • 00810021837505 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
MTPJ Plate Large Left, 5 deg Dorsiflexion/5 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12320255
In Commercial Distribution

  • B471123202550 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Large Left, 0 deg Dorsiflexion/0 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12320200
In Commercial Distribution

  • B471123202000 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Medium Left, 5 deg Dorsiflexion/5 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12320155
In Commercial Distribution

  • B471123201550 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Medium Left, 5 deg Dorsiflexion/0 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12320150
In Commercial Distribution

  • B471123201500 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Medium Left, 0 deg Dorsiflexion/5 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12320105
In Commercial Distribution

  • B471123201050 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Medium Left, 0 deg Dorsiflexion/0 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12320100
In Commercial Distribution

  • B471123201000 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Small Left, 5 deg Dorsiflexion/5 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12320055
In Commercial Distribution

  • B471123200550 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Small Left, 5 deg Dorsiflexion/0 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12320050
In Commercial Distribution

  • B471123200500 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Small Left, 0 deg Dorsiflexion/5 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12320005
In Commercial Distribution

  • B471123200050 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Small Left, 0 deg Dorsiflexion/0 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12320000
In Commercial Distribution

  • B471123200000 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Large Right, 5 deg Dorsiflexion/5 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12020255
In Commercial Distribution

  • B471120202550 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Large Right, 0 deg Dorsiflexion/0 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12020200
In Commercial Distribution

  • B471120202000 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Medium Right, 5 deg Dorsiflexion/5 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12020155
In Commercial Distribution

  • B471120201550 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Medium Right, 5 deg Dorsiflexion/0 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12020150
In Commercial Distribution

  • B471120201500 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Medium Right, 0 deg Dorsiflexion/5 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12020105
In Commercial Distribution

  • B471120201050 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Medium Right, 0 deg Dorsiflexion/0 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12020100
In Commercial Distribution

  • B471120201000 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Small Right, 5 deg Dorsiflexion/5 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12020055
In Commercial Distribution

  • B471120200550 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Small Right, 5 deg Dorsiflexion/0 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12020050
In Commercial Distribution

  • B471120200500 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Small Right, 0 deg Dorsiflexion/5 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12020005
In Commercial Distribution

  • B471120200050 ()


  • Orthopaedic fixation plate, non-bioabsorbable
MTPJ Plate Small Right, 0 deg Dorsiflexion/0 deg Abduction, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
12020000
In Commercial Distribution

  • B471120200000 ()


  • Orthopaedic fixation plate, non-bioabsorbable
Tempus ECG-AF is a cardiovascular machine learning-based notification software intended to analyze recordings of 12-lead ECG devices from patients 65 years of age and older. The software employs machine learning techniques to analyze ECG recordings and detect signs associated with a patient experiencing atrial fibrillation and/or atrial flutter (collectively referred to as AF) within the next 12 months. The device is designed to extract otherwise unavailable information from ECGs conducted under the standard of care, to help health care providers better identify patients who may be at risk for undiagnosed AF in order to evaluate them for referral of further diagnostic follow up and address the unmet need of reducing the number of undiagnosed AF patients.
Tempus AI, Inc.
3
In Commercial Distribution

  • 00860011843603 ()


  • Cardiopulmonary physiological parameter analysis software
Cutting aid
Etac Supply Center AB
Cut
In Commercial Distribution

  • 07320450086670 ()
80501005

  • Food cutting/chopping aid
Cheese slicer
Etac Supply Center AB
Relieve
In Commercial Distribution

  • 07320450002373 ()
80502001

  • Food cutting/chopping aid
Carving knife, angled
Etac Supply Center AB
Relieve
In Commercial Distribution

  • 07320450002366 ()
80501101

  • Food cutting/chopping aid
Preparation board
Etac Supply Center AB
Fix
In Commercial Distribution

  • 07320450002342 ()
80501004

  • Food cutting/chopping aid
Knife, angled, small
Etac Supply Center AB
Relieve
In Commercial Distribution

  • 07320450002120 ()
80402102

  • Food cutting/chopping aid
Knife, angled
Etac Supply Center AB
Relieve
In Commercial Distribution

  • 07320450002113 ()
80402101

  • Food cutting/chopping aid
The Model 300126 Battery Power Subassembly is Model 3001-C Battery Charger and QTY 2 Model 100026 Batteries as a subassembly, but is packaged separately from a system configuration.
VITA HEAT MEDICAL
300126
In Commercial Distribution

  • 00851446007081 ()


  • Primary battery
  • Noninvasive device battery charger
Software application that uses machine learning to assess breast tissue composition.
Ai Whiterabbit Inc
WRDensity-1
In Commercial Distribution

  • 00860005853601 ()


  • Radiology DICOM image processing application software
Portable reverse osmosis machine for water purification for dialysis applications. 220V.
BETTER WATER, LLC
EQROPB01600
In Commercial Distribution

  • PB0002 ()
EQROPB01600

  • Combination water purification system
Detached machine cord for P143 Bovie Model Number should be 77520-1
GRACE MANUFACTURING, INC.
27520-01
In Commercial Distribution

  • 10801334006457 ()

  • Length: 10 Feet
P143C

  • Electrical-only medical device connection cable, reprocessed
Ecg machine lead adapter /GE Kiss/ ten lead /IEC/ 1.47m + 1.27m
Unimed Medical Supplies, Inc.
38401590-A
In Commercial Distribution

  • 06945664891974 ()


  • Electrocardiographic lead set, reusable
No Description
INFINIUM MEDICAL, INC.
OBA Anesthesia Machine
In Commercial Distribution

  • 00852087007881 ()


  • Anaesthesia workstation, general-purpose
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