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

  • 30014613333012 ()
55-2408DF

  • Cell culture line IVD
ELVIS MWP W24/8F CUST
DIAGNOSTIC HYBRIDS, INC.
55-2408CB
In Commercial Distribution

  • 30014613333005 ()
55-2408CB

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

  • 30014613332992 ()
55-2406S

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

  • 30014613332985 ()
55-2406DE

  • Cell culture line IVD
ELVIS MWP W24/6F
DIAGNOSTIC HYBRIDS, INC.
55-2406
In Commercial Distribution

  • 30014613332978 ()
55-2406

  • Cell culture line IVD
ELVIS SV/CS
DIAGNOSTIC HYBRIDS, INC.
55-0102
In Commercial Distribution

  • 30014613332961 ()
55-0102

  • Cell culture line IVD
ELVIS SV WITHOUT CS
DIAGNOSTIC HYBRIDS, INC.
55-0101
In Commercial Distribution

  • 30014613332954 ()
55-0101

  • Cell culture line IVD
No Description
Edwards Lifesciences LLC
4700
In Commercial Distribution

  • 00690103144178 ()

  • 10 CENTIMETERS WIDE BY 15 CENTIMETERS LONG. USER WILL TAILOR TO DESIRED SIZE.
4700

  • Cardiovascular patch, animal-derived
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
EARP, 14X25X08 0° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP1425-0008
In Commercial Distribution

  • 00810135960007 ()

  • Depth: 14 Millimeter
  • Width: 25 Millimeter
  • Height: 8 Millimeter


  • Polymeric spinal interbody fusion cage
E-Z LINK
MEGADYNE MEDICAL PRODUCTS, INC.
MGEZLINK01
In Commercial Distribution

  • 10614559104460 ()
MGEZLINK01

  • Surgical plume evacuation system
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP2X9
In Commercial Distribution

  • 00690103199048 ()

  • 2 CM X 9 CM
DP2X9

  • Cardiovascular patch, animal-derived
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP1X6
In Commercial Distribution

  • 00690103199031 ()

  • 1 CM X 6 CM
DP1X6

  • Cardiovascular patch, animal-derived
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP08X8
In Commercial Distribution

  • 00690103199024 ()

  • 0.8 CM X 8 CM
DP08X8

  • Cardiovascular patch, animal-derived
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Drive Headstage
In Commercial Distribution

  • 07290114061520 ()
700-006000-00

  • Depth electrode
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906AB
In Commercial Distribution

  • 00840682121446 ()


  • Stationary gamma camera system
  • Full-body CT system
UFC GANTRY FINAL ASSEMBLY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3000SA
In Commercial Distribution

  • 00840682105286 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100AH
In Commercial Distribution

  • 00840682121194 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100AG
In Commercial Distribution

  • 00840682121187 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100JY
In Commercial Distribution

  • 00840682115292 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT 670 ES
In Commercial Distribution

  • 00840682139403 ()


  • Full-body CT system
  • Stationary gamma camera system
D670 CZT GANTRY 7.25mm WITH NEW ROTOR
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT 670 CZT
In Commercial Distribution

  • 00840682139380 ()


  • Full-body CT system
  • Stationary gamma camera system
D670 PRO NM GANTRY FINAL - NEW ROTOR
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT 670 PRO
In Commercial Distribution

  • 00840682139373 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
670 DR
In Commercial Distribution

  • 00840682139359 ()


  • Stationary gamma camera system
  • Full-body CT system
D630 NM GANTRY FINAL - NEW ROTOR
G E MEDICAL SYSTEMS ISRAEL LTD.
NM 630
In Commercial Distribution

  • 00840682139274 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
670 DR
In Commercial Distribution

  • 00840682124393 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT 670 ES
In Commercial Distribution

  • 00840682123877 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT 670 CZT
In Commercial Distribution

  • 00840682123853 ()


  • Full-body CT system
  • Stationary gamma camera system
Depthalon Electrode, Platinum, 7 Macro Contacts, 16 Microwire contacts, 52mm recording length, Mini connector, 1 exit, 4 leads, 4 exits
PMT CORPORATION
2104-07-057-003
In Commercial Distribution

  • 00650551144571 ()


  • Depth electrode
Depthalon Electrode, Platinum, 7 Macro Contacts, 57 Microwire contacts, 44mm recording length, Mini connector, 1 exit, 4 leads, 4 exits
PMT CORPORATION
2104-07-057-002
In Commercial Distribution

  • 00650551144564 ()


  • Depth electrode
Depthalon Electrode, Platinum, 8 Macro Contacts, 16 Microwire contacts, 38.5mm recording length, Miniconnector, 1 exit, 2 leads, 2 exits
PMT CORPORATION
2104-08-16-004
In Commercial Distribution

  • 00650551144465 ()


  • Depth electrode
Depthalon Electrode, Platinum, Non-sterile, 8 Macro Contacts, 16 Microwire contacts, 38.5mm recording length, Inline connector, 1 exit, 2 leads, 2 exits
PMT CORPORATION
2104-08-16-003-NS
In Commercial Distribution

  • 00650551144403 ()


  • Depth electrode
Depthalon Electrode, Platinum, 8 Macro Contacts, 16 Microwire contacts, 38.5mm recording length, Inline connector, 1 exit, 2 leads, 2 exits
PMT CORPORATION
2104-08-16-003
In Commercial Distribution

  • 00650551144397 ()


  • Depth electrode
Depthalon sEEG Electrode, Platinum, 4 contacts, 17mm recording length, Mini connector, 1 Exit, 1 Lead, 1 Tail
PMT CORPORATION
2102-04-145
In Commercial Distribution

  • 00650551144380 ()


  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
MM31A-SP53X-000
In Commercial Distribution

  • 00841823109576 ()
MM31A-SP53X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
MM29A-SP52X-000
In Commercial Distribution

  • 00841823109569 ()
MM29A-SP52X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
MM32D-SP05X-000
In Commercial Distribution

  • 00841823109552 ()
MM32D-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD16R-SP05X-000
In Commercial Distribution

  • 00841823109033 ()
RD16R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD16R-SP03X-000
In Commercial Distribution

  • 00841823109026 ()
RD16R-SP03X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD14R-SP03X-000
In Commercial Distribution

  • 00841823109002 ()
RD14R-SP03X-000

  • Depth electrode
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