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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Brachytherapy
RIVERPOINT MEDICAL, LLC
1100-1812X
In Commercial Distribution

  • 00812444027310 ()
  • 10812444027317 ()
  • 20812444027314 ()


  • Brachytherapy injection needle
CoolMax
Zeltiq Aesthetics, Inc.
BRZ-AP1-080-000
In Commercial Distribution

  • 00816417020230 ()
BRZ-AP1-080-000

  • Cryolipolysis body contouring system applicator
No Description
SOPRO-COMEG GmbH
191 060 341
In Commercial Distribution

  • 04059082005065 ()


  • Vaginal applicator, reusable
No Description
SOPRO-COMEG GmbH
191 060 331
In Commercial Distribution

  • 04059082005058 ()


  • Vaginal applicator, reusable
Kerr Applicators; Red & Black Applicator Tips; Refill
Kerr Corporation
27511
In Commercial Distribution

  • 10841396107327 ()
  • 00841396107320 ()
27511

  • Dental material application tool, single-use
No Description
Surgident Co.,Ltd.
TA-01
In Commercial Distribution

  • 08800041053469 ()


  • Bone tack inserter, basic
No Description
Surgident Co.,Ltd.
SD-HD01
In Commercial Distribution

  • 08800041041374 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
Surgident Co.,Ltd.
TR-03
In Commercial Distribution

  • 08800041039135 ()


  • Surgical screwdriver, reusable
Manual applicator for Expasyl paste (sulcular opening paste).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243000782 ()
  • 03760243007057 ()
260900

  • Gingival retraction kit
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1352
Not in Commercial Distribution

  • 04953170175626 ()


  • Surgical instrument assist arm system, manually-adjusted
"MD-688 Balloon applicator for JF-UM20"
OLYMPUS MEDICAL SYSTEMS CORP.
MD-688
Not in Commercial Distribution

  • 04953170065262 ()


  • Surgical instrument assist arm system, manually-adjusted
"6842600 OLA MAJ-864 RADIAL SCOPE BALLOON"
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-864
Not in Commercial Distribution

  • 04953170062865 ()


  • Surgical instrument assist arm system, manually-adjusted
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-675
In Commercial Distribution

  • 04953170061912 ()


  • Surgical instrument assist arm system, manually-adjusted
5792300 OLA MAJ-564 BALLOON APPLICATOR F
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-564
In Commercial Distribution

  • 04953170061899 ()


  • Surgical instrument assist arm system, manually-adjusted
"MH-526 Balloon applicator for MH-908"
OLYMPUS MEDICAL SYSTEMS CORP.
MH-526
Not in Commercial Distribution

  • 04953170055553 ()


  • Surgical instrument assist arm system, manually-adjusted
"MAJ-675 Balloon applicator for GF-UC30P"
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-675
In Commercial Distribution

  • 04953170356001 ()


  • Surgical instrument assist arm system, manually-adjusted
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-564
In Commercial Distribution

  • 04953170368547 ()


  • Surgical instrument assist arm system, manually-adjusted
MAJ-1352 BALLOON APP. FOR EBUS BRONCHSCP
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1352
In Commercial Distribution

  • 04953170355981 ()


  • Surgical instrument assist arm system, manually-adjusted
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-864
In Commercial Distribution

  • 04953170355974 ()


  • Surgical instrument assist arm system, manually-adjusted
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MH-526
Not in Commercial Distribution

  • 04953170355752 ()


  • Surgical instrument assist arm system, manually-adjusted
5 x 7 cm Ellipsoidal, Extended Length
Icad, Inc.
720849
In Commercial Distribution

  • 00850008977015 ()
AB2073E

  • Intraoperative/postoperative therapeutic x-ray system balloon applicator kit
5-6 cm Spherical Extended Length
Icad, Inc.
720848
In Commercial Distribution

  • 00850008977008 ()
AB2072

  • Intraoperative/postoperative therapeutic x-ray system balloon applicator kit
Handpiece applicator for EpilMe System
NEAUVIA NORTH AMERICA, INC.
300-1701
In Commercial Distribution

  • 00850017374218 ()


  • Dermatological solid-state laser system
Uebe Applicator Cross Serrated End
SONTEC INSTRUMENTS, INC.
467-567
In Commercial Distribution

  • 00192896108868 ()

  • Length: 7 Inch


  • General-purpose absorbent tip applicator/swab, reusable
Farrell Applicator Cross Serrated End
SONTEC INSTRUMENTS, INC.
467-550
In Commercial Distribution

  • 00192896108844 ()

  • Length: 5.5 Inch


  • General-purpose absorbent tip applicator/swab, reusable
FARRELL APPLICATOR TRIANGLE END MINATURE HANDLE
SONTEC INSTRUMENTS, INC.
467-555
In Commercial Distribution

  • 00192896040342 ()

  • Length: 5 Inch
467-555

  • General-purpose absorbent tip applicator/swab, reusable
FARRELL APPLICATOR CROSS SERRATED END
SONTEC INSTRUMENTS, INC.
467-551
In Commercial Distribution

  • 00192896040335 ()

  • Length: 6.25 Inch
467-551

  • General-purpose absorbent tip applicator/swab, reusable
Micasept Applicator For Robotic Debakey Bulldog Forcep Pistol Grip With Ratchet Angled
SONTEC INSTRUMENTS, INC.
26932-60
In Commercial Distribution

  • 00192896115989 ()

  • 350.00 Millimeter Working Length
  • Outer Diameter: 10 Millimeter
26932-60

  • Open-surgery ligation clip applier
Micasept Applicator For Robotic Debakey Bulldog Forceps Pistol Grip With Ratchet Straight
SONTEC INSTRUMENTS, INC.
26932-62
In Commercial Distribution

  • 00192896117389 ()

  • Length: 380 Millimeter
  • Outer Diameter: 10 Millimeter
26932-62

  • Open-surgery ligation clip applier
An at home intravaginal insemination system to deliver semen to the vaginal canal for insemination.
HANNAH LIFE TECHNOLOGIES PTE. LTD.
HC01
In Commercial Distribution

  • 08881300389024 ()


  • Home-use artificial insemination kit
4-5 cm Spherical Extended Length
Icad, Inc.
720847
In Commercial Distribution

  • 00858012005991 ()
AB2071

  • Intraoperative/postoperative therapeutic x-ray system balloon applicator kit
3-4 cm Spherical, Extended Length
Icad, Inc.
720846
In Commercial Distribution

  • 00858012005984 ()
AB2070

  • Intraoperative/postoperative therapeutic x-ray system balloon applicator kit
No Description
HELENA LABORATORIES CORPORATION
1265000
In Commercial Distribution

  • M52512650000 ()


  • Protein electrophoresis IVD, kit, electrophoresis
MUPIT Stopper for 1.9mm Needle
Nucletron B.V.
045303P02-00
In Commercial Distribution

  • 08717213002951 ()
  • 08717213052185 ()
  • 88717213002957 ()

  • Device Size Text, specify:
  • Outer Diameter: 1.9 Millimeter


  • General-purpose brachytherapy system applicator, remote-afterloading
Trocar Needle 1.9mm x 120mm
Nucletron B.V.
083054P02-00
In Commercial Distribution

  • 08717213007055 ()
  • 08717213051430 ()
  • 88717213051430 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
MUPIT Bolt M3 x 5mm
Nucletron B.V.
110069P01-01
In Commercial Distribution

  • 08717213043077 ()
  • 08717213043060 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
Locking Nut Perineal Bar
Nucletron B.V.
084919P01-01
In Commercial Distribution

  • 08717213043152 ()
  • 08717213042971 ()


  • Vaginal brachytherapy system applicator, remote-afterloading
Rectal Retractor, 90deg
Nucletron B.V.
084338P01-03
In Commercial Distribution

  • 08717213008595 ()
  • 08717213042964 ()


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading
MUPIT Base Plate Small
Nucletron B.V.
083590P01-03
In Commercial Distribution

  • 08717213007581 ()
  • 08717213042315 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
MUPIT Base Plate, Large
Nucletron B.V.
083589P01-03
In Commercial Distribution

  • 08717213007574 ()
  • 08717213042308 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
MUPIT Base Plate Filler, 12mm Hole
Nucletron B.V.
083588P01-03
In Commercial Distribution

  • 08717213007567 ()
  • 08717213042292 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
MUPIT Rectal Cylinder
Nucletron B.V.
083586P01-03
In Commercial Distribution

  • 08717213007543 ()
  • 08717213042285 ()

  • Outer Diameter: 25.4 Millimeter
  • Device Size Text, specify:


  • General-purpose brachytherapy system applicator, remote-afterloading
MUPIT Vaginal Cylinder
Nucletron B.V.
083581P01-03
In Commercial Distribution

  • 08717213007536 ()
  • 08717213042278 ()

  • Device Size Text, specify:
  • Outer Diameter: 25.4 Millimeter


  • General-purpose brachytherapy system applicator, remote-afterloading
MUPIT Cylinder Adapter, 1.9mm Needle
Nucletron B.V.
083289P01-03
In Commercial Distribution

  • 08717213007406 ()
  • 08717213042261 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
MUPIT Vaginal cylinder
Nucletron B.V.
045461P01-03
In Commercial Distribution

  • 08717213003163 ()
  • 08717213042254 ()

  • Length: 130.0 Millimeter
  • Outer Diameter: 25.4 Millimeter
  • Device Size Text, specify:


  • General-purpose brachytherapy system applicator, remote-afterloading
MUPIT Rectal Cylinder
Nucletron B.V.
045460P01-03
In Commercial Distribution

  • 08717213003156 ()
  • 08717213042247 ()

  • Device Size Text, specify:
  • Length: 130.0 Millimeter
  • Outer Diameter: 25.4 Millimeter


  • General-purpose brachytherapy system applicator, remote-afterloading
MUPIT Base Plate, Small
Nucletron B.V.
045459P01-03
In Commercial Distribution

  • 08717213003149 ()
  • 08717213042230 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
MUPIT Base Plate, large
Nucletron B.V.
045458P01-03
In Commercial Distribution

  • 08717213003132 ()
  • 08717213042223 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
MUPIT Base Plate Filler, 12 mm hole
Nucletron B.V.
045457P01-03
In Commercial Distribution

  • 08717213003125 ()
  • 08717213042216 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
MUPIT Cover Plate Filler, 8 mm hole
Nucletron B.V.
045449P01-03
In Commercial Distribution

  • 08717213003088 ()
  • 08717213042209 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
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