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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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E.M Adams co, inc. - 18100013407403

BELT
E.M. ADAMS, INC.
EP26-63375-1
Not in Commercial Distribution

  • 58100013407395 ()
  • 18100013407403 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407380

BELT
E.M. ADAMS, INC.
EP26-63350XL-1
Not in Commercial Distribution

  • 58100013407371 ()
  • 18100013407380 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407366

BELT
E.M. ADAMS, INC.
EP26-63350-1
Not in Commercial Distribution

  • 58100013407357 ()
  • 18100013407366 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407342

BELT
E.M. ADAMS, INC.
EP26-63340XL-1
Not in Commercial Distribution

  • 58100013407333 ()
  • 18100013407342 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness

ECAM-SCINTRON - 04260484140036

The ECAM SCINTRON Gamma Camera System is a remanufactured Siemens Gamma Camera with MiE Workstation. It is designed for diagnostic nuclear medicine used to perform static, dynamic and gated studies (non positron emitting tomography), as well as SPECT or planar procedure on standing, seated or recumbent patients. The ECAM SCINTRON Gamma Camera System is substantially equivalent to the legally market device e.cam, K963983, from Siemens and our device SCINTRON, K101 01 3. The changes incorporated into the remanufactured ECAM Gamma Camera include economical and ecological issues. This closes the gap between more durable electronics and mechanics lifetimes and shortened development cycles.
MiE medical imaging electronics GmbH
ECAM-SCINTRON
In Commercial Distribution

  • 04260484140036 ()


  • Stationary gamma camera system

ELVIS - 30014613333098

ELVIS MWP W24/24F W/CS
DIAGNOSTIC HYBRIDS, INC.
55-2424S
In Commercial Distribution

  • 30014613333098 ()
55-2424S

  • Cell culture line IVD

ELVIS - 30014613333081

ELVIS MWP W24/24F
DIAGNOSTIC HYBRIDS, INC.
55-2424
In Commercial Distribution

  • 30014613333081 ()
55-2424

  • Cell culture line IVD

ELVIS - 30014613333074

ELVIS MWP W24/18F WITH CS
DIAGNOSTIC HYBRIDS, INC.
55-2418S
In Commercial Distribution

  • 30014613333074 ()
55-2418S

  • Cell culture line IVD

ELVIS - 30014613333067

ELVIS MWP W24/18F
DIAGNOSTIC HYBRIDS, INC.
55-2418
In Commercial Distribution

  • 30014613333067 ()
55-2418

  • Cell culture line IVD

ELVIS - 30014613333050

ELVIS MWP W24/12F W/CS
DIAGNOSTIC HYBRIDS, INC.
55-2412S
In Commercial Distribution

  • 30014613333050 ()
55-2412S

  • Cell culture line IVD

ELVIS - 30014613333043

ELVIS MWP W24/12F
DIAGNOSTIC HYBRIDS, INC.
55-2412
In Commercial Distribution

  • 30014613333043 ()
55-2412

  • Cell culture line IVD

ELVIS - 30014613333036

ELVIS MWP W24/10F W/CS
DIAGNOSTIC HYBRIDS, INC.
55-2410S
In Commercial Distribution

  • 30014613333036 ()
55-2410S

  • Cell culture line IVD

ELVIS - 30014613333029

ELVIS MWP W24/9F
DIAGNOSTIC HYBRIDS, INC.
55-2409
In Commercial Distribution

  • 30014613333029 ()
55-2409

  • Cell culture line IVD

ELVIS - 30014613333012

ELVIS MWP W24/8F CUST FILL
DIAGNOSTIC HYBRIDS, INC.
55-2408DF
In Commercial Distribution

  • 30014613333012 ()
55-2408DF

  • Cell culture line IVD

ELVIS - 30014613333005

ELVIS MWP W24/8F CUST
DIAGNOSTIC HYBRIDS, INC.
55-2408CB
In Commercial Distribution

  • 30014613333005 ()
55-2408CB

  • Cell culture line IVD

ELVIS - 30014613332992

ELVIS MWP W24/6F W/CS
DIAGNOSTIC HYBRIDS, INC.
55-2406S
In Commercial Distribution

  • 30014613332992 ()
55-2406S

  • Cell culture line IVD

ELVIS - 30014613332985

ELVIS MWP W24/6F CUST FILL
DIAGNOSTIC HYBRIDS, INC.
55-2406DE
In Commercial Distribution

  • 30014613332985 ()
55-2406DE

  • Cell culture line IVD

ELVIS - 30014613332978

ELVIS MWP W24/6F
DIAGNOSTIC HYBRIDS, INC.
55-2406
In Commercial Distribution

  • 30014613332978 ()
55-2406

  • Cell culture line IVD

ELVIS - 30014613332961

ELVIS SV/CS
DIAGNOSTIC HYBRIDS, INC.
55-0102
In Commercial Distribution

  • 30014613332961 ()
55-0102

  • Cell culture line IVD

ELVIS - 30014613332954

ELVIS SV WITHOUT CS
DIAGNOSTIC HYBRIDS, INC.
55-0101
In Commercial Distribution

  • 30014613332954 ()
55-0101

  • Cell culture line IVD

ESU Sensor - 00817688021742

No Description
I.C. MEDICAL, INC.
2250
Not in Commercial Distribution

  • 00817688021742 ()
ICM-000-0422

  • Surgical plume evacuation system

ESU Sensor - 00817688021711

No Description
I.C. MEDICAL, INC.
ICM-000-0009
In Commercial Distribution

  • 00817688021711 ()


  • Surgical plume evacuation system

EasyVac - 30845854081017

EasyVac Kit (1) EASYVAC 120V, (1) VSTR08, (1) EZLINK01, (1) FS10004, (3) S-PA2010, (2) BLAP100V, (3) S-VTWT624
Conmed Corporation
EASYVACKIT
In Commercial Distribution

  • 30845854081017 ()
EASYVACKIT

  • Surgical plume evacuation system

Electrode Delivery Tool Kit MedCoat, CE - 00852184003373

No Description
Synapse Biomedical, Inc.
22-0018
In Commercial Distribution

  • 00852184003373 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Electrode Delivery Tool Kit, MedCoat, HDE - 00852184003465

No Description
Synapse Biomedical, Inc.
22-0034
In Commercial Distribution

  • 00852184003465 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

EvacuCart - 00851136002396

Portable Cart for Smoke Evacuators
Buffalo Filter
ETC01
Not in Commercial Distribution

  • 00851136002396 ()


  • Surgical plume evacuation system

Extended-Life Battery - 3 Pack - 00852184003380

No Description
Synapse Biomedical, Inc.
22-0020
In Commercial Distribution

  • 00852184003380 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

FREND - 08809317540825

FREND™ Blocking Reagent is provided in 15 tubes, the blocking reagent is buffer based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The Blocking Reagent is provided in a dried solid state.
NanoEnTek, Inc.
FREND Blocking Reagent
In Commercial Distribution

  • 08809317540825 ()
FRBR 015

  • Immunohistochemistry endogenous protein blocking reagent IVD

FREND - 08809317540566

FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System only. FREND™ TSH Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution.
NanoEnTek, Inc.
FREND Vitamin D Linearity Kit
In Commercial Distribution

  • 08809317540566 ()
FLK-VTD

  • Non-blood cell primer/calibrator/control material IVD, reagent

FREND - 08809317540559

FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System only. FREND™ TSH Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution.
NanoEnTek, Inc.
FREND TSH Linearity Kit
In Commercial Distribution

  • 08809317540559 ()
FLK-TSH

  • Non-blood cell primer/calibrator/control material IVD, reagent
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