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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No Description
QUALITY ELECTRODYNAMICS LLC
Q7000057
In Commercial Distribution

  • 00814848020355 ()


  • MRI system coil, radio-frequency
No Description
QUALITY ELECTRODYNAMICS LLC
Q7000056
In Commercial Distribution

  • 00814848020331 ()


  • MRI system coil, radio-frequency
USED LP15,EN,SPO2,3L,EX,CO2,TR,VR,MNC,V4
PHYSIO-CONTROL, INC.
99577
In Commercial Distribution

  • 07613327666663 ()
99577-002178U

  • Physiologic-monitoring defibrillation system
USED LP15,EN,SPO2,3L,EX,CO2,TR,VR,BT,MNC,V4
PHYSIO-CONTROL, INC.
99577
In Commercial Distribution

  • 07613327666649 ()
99577-002166U

  • Physiologic-monitoring defibrillation system
No Description
Aktina Corp.
11-495-15
In Commercial Distribution

  • B36511495150 ()


  • X-ray/radiation therapy beam filter, wedge
USED LP15,EN,SPO2COMET,3L/12L,EX,NIBP,CO2,IP,TR,VR,V4
PHYSIO-CONTROL, INC.
99577
In Commercial Distribution

  • 07613327650839 ()
99577-001937U

  • Physiologic-monitoring defibrillation system
USED LP15,EN,3L,EX,VR,V4
PHYSIO-CONTROL, INC.
99577
In Commercial Distribution

  • 07613327650792 ()
99577-001930U

  • Physiologic-monitoring defibrillation system
Flavored Hemostatic retraction solution for topical dental application with 25% aluminum sulfate, 15 mL
PASCAL COMPANY, INC.
15600
In Commercial Distribution

  • 00310866000817 ()
15600

  • Gingival retraction solution
Absorbent Paper Points, 02 Taper 15, 200 Points, P 21
Meta Biomed Co., Ltd.
2845
In Commercial Distribution

  • 08806387828457 ()


  • Endodontic paper point
Absorbent Paper Points, 02 Taper 15, 200 Points, P 31R
Meta Biomed Co., Ltd.
2718
In Commercial Distribution

  • 08806387827184 ()


  • Endodontic paper point
Absorbent Paper Points, 02 Taper 15, 200 Points, P 31S
Meta Biomed Co., Ltd.
2606
In Commercial Distribution

  • 08806387826064 ()


  • Endodontic paper point
Absorbent Paper Points, 02 Taper 15, 200 Points, P 61
Meta Biomed Co., Ltd.
2496
In Commercial Distribution

  • 08806387824961 ()


  • Endodontic paper point
Absorbent Paper Points, 02 Taper 15, 120 Points, P 71
Meta Biomed Co., Ltd.
2377
In Commercial Distribution

  • 08806387823773 ()


  • Endodontic paper point
Absorbent Paper Points, 02 Tape15, 200 Points, P 71
Meta Biomed Co., Ltd.
2234
In Commercial Distribution

  • 08806387822349 ()


  • Endodontic paper point
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
3910-500-773
In Commercial Distribution

  • 10818674028278 ()
605300st

  • Clamp manipulation forceps
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
214137
In Commercial Distribution

  • 10818674021200 ()
727431m

  • Clamp manipulation forceps
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10818674022238 ()
733231t

  • Cast cutting shears
Scissors, 15°, double-action , Tube-shaf ValveGate™PRO Ø5 17cm
Geister Medizintechnik GmbH
38-7830S
In Commercial Distribution

  • 04057034132296 ()
38-7830S

  • General-purpose surgical scissors, reusable
Scissors, 15°, double-action , Tube-shaf ValveGate™classic Ø5 17cm
Geister Medizintechnik GmbH
34-7830S
In Commercial Distribution

  • 04057034122976 ()
34-7830S

  • General-purpose surgical scissors, reusable
No Description
NARVA Lichtquellen GmbH + Co KG.
FR79 T12 120W PH / BiPin
Not in Commercial Distribution

  • 84014501000997 ()
  • 54014501400994 ()
  • 04014501000991 ()
22015

  • Ultraviolet tanning device
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190013257 ()
PF1-0073

  • Dental implant system
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190018498 ()
398331j

  • Clamp manipulation forceps
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190018085 ()
783231

  • Cast cutting shears
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190017972 ()
753231

  • Cast cutting shears
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190017897 ()
743231

  • Cast cutting shears
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190017408 ()
723231

  • Cast cutting shears
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190017378 ()
713231

  • Cast cutting shears
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190017156 ()
727431t

  • Clamp manipulation forceps
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
E
In Commercial Distribution

  • 10810190015787 ()
727431st

  • Clamp manipulation forceps
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190014865 ()
783231a

  • Cast cutting shears
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190014759 ()
753231a

  • Cast cutting shears
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190014674 ()
743231a

  • Cast cutting shears
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190014636 ()
733231a

  • Cast cutting shears
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190014575 ()
723231a

  • Cast cutting shears
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190014537 ()
713231a

  • Cast cutting shears
No Description
W.H. Holden, Inc.
10-7141
In Commercial Distribution

  • D9281071410 ()


  • Dental suction system cannula, reusable
No Description
W.H. Holden, Inc.
40-0520H
In Commercial Distribution

  • D928400520H0 ()


  • Periotome, reusable
Multidil 15 ReadyPack (2PK) - CENTAUR - 2x25 mL
Siemens Healthcare Diagnostics Inc.
11200097
In Commercial Distribution

  • 00630414211015 ()
  • 00630414223513 ()
11200097

  • Buffered sample diluent IVD
No Description
BIOCARE MEDICAL LLC
PFA7218V
In Commercial Distribution

  • 00847627000569 ()


  • Nucleic acid hybridization detection IVD, probe
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600290-001
In Commercial Distribution

  • J00716002900011 ()
1600290-001

  • Dental power tool system handpiece, remotely-driven
The Global Reference Module 15 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 15
In Commercial Distribution

  • 00850011306659 ()
31-0604-0057

  • Electroencephalographic signal amplifier
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S0005
In Commercial Distribution

  • 00849405011507 ()


  • Negative-pressure wound therapy system, electric, single-use
No Description
Hasa Optix
HA-SET015
In Commercial Distribution

  • 05404027446653 ()
  • 05404027444635 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-115
In Commercial Distribution

  • 09348215074784 ()


  • Surgical implant template, reusable
No Description
edelweiss dentistry products gmbh
13205
In Commercial Distribution

  • 09120046321455 ()


  • Dental veneer, professional
  • Dental composite resin
No Description
edelweiss dentistry products gmbh
13204
In Commercial Distribution

  • 09120046321448 ()


  • Dental composite resin
  • Dental veneer, professional
No Description
edelweiss dentistry products gmbh
13203
In Commercial Distribution

  • 09120046321431 ()


  • Dental veneer, professional
  • Dental composite resin
No Description
edelweiss dentistry products gmbh
13105
In Commercial Distribution

  • 09120046321172 ()


  • Dental composite resin
  • Dental veneer, professional
No Description
edelweiss dentistry products gmbh
13104
In Commercial Distribution

  • 09120046321165 ()


  • Dental composite resin
  • Dental veneer, professional
No Description
edelweiss dentistry products gmbh
13103
In Commercial Distribution

  • 09120046321158 ()


  • Dental composite resin
  • Dental veneer, professional
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