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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8' HOSE ASMLBY US VAC OF*OM COND 1/4"
OHIO MEDICAL, LLC
HS-08UV-OFOMC4
In Commercial Distribution

  • 00628101545963 ()
HS-08UV-OFOMC4

  • General-gas low pressure tubing, reusable
8FT HS ASM US VAC OF*DM 5/16'' COND
OHIO MEDICAL, LLC
HS-08UV-OFDMC5
In Commercial Distribution

  • 00628101545956 ()
HS-08UV-OFDMC5

  • General-gas low pressure tubing, reusable
08FT HS ASM US VAC OF*CM 5/16'' COND
OHIO MEDICAL, LLC
HS-08UV-OFCMC5
In Commercial Distribution

  • 00628101545949 ()
HS-08UV-OFCMC5

  • General-gas low pressure tubing, reusable
8' HOSE ASMBLY US VAC M4*M4 COND 5/16"
OHIO MEDICAL, LLC
HS-08UV-M4M4C5
In Commercial Distribution

  • 00628101545932 ()
HS-08UV-M4M4C5

  • General-gas low pressure tubing, reusable
8' HOSE ASMB USA VAC M2*OM COND 5/16"
OHIO MEDICAL, LLC
HS-08UV-M2OMC5
In Commercial Distribution

  • 00628101545925 ()
HS-08UV-M2OMC5

  • General-gas low pressure tubing, reusable
8' HOSE ASMBLY USA M2*OM COND 1/4"
OHIO MEDICAL, LLC
HS-08UV-M2OMC4
In Commercial Distribution

  • 00628101545918 ()
HS-08UV-M2OMC4

  • General-gas low pressure tubing, reusable
8' HOSE ASMBLY USA VAC M2*MM 5/16" CON
OHIO MEDICAL, LLC
HS-08UV-M2MMC5
In Commercial Distribution

  • 00628101545901 ()
HS-08UV-M2MMC5

  • General-gas low pressure tubing, reusable
8' HOSE ASMBLY USA VAC F4*OM CON 5/16"
OHIO MEDICAL, LLC
HS-08UV-F4OMC5
In Commercial Distribution

  • 00628101545895 ()
HS-08UV-F4OMC5

  • General-gas low pressure tubing, reusable
8' HOSE ASMBLY USA VAC F4*MM CON 5/16"
OHIO MEDICAL, LLC
HS-08UV-F4MMC5
In Commercial Distribution

  • 00628101545888 ()
HS-08UV-F4MMC5

  • General-gas low pressure tubing, reusable
8' HOSE ASMB USA VAC F4*M4 COND 1/4"
OHIO MEDICAL, LLC
HS-08UV-F4M4C4
In Commercial Distribution

  • 00628101545871 ()
HS-08UV-F4M4C4

  • General-gas low pressure tubing, reusable
8' HOSE ASMBLY US VAC F4*F4 COND 5/16"
OHIO MEDICAL, LLC
HS-08UV-F4F4C5
In Commercial Distribution

  • 00628101545864 ()
HS-08UV-F4F4C5

  • General-gas low pressure tubing, reusable
08FT HS ASM US VAC F4*F4 1/4'' COND
OHIO MEDICAL, LLC
HS-08UV-F4F4C4
In Commercial Distribution

  • 00628101545857 ()
HS-08UV-F4F4C4

  • General-gas low pressure tubing, reusable
8 FT HS ASM US VAC F2*XX 5/16'' COND
OHIO MEDICAL, LLC
HS-08UV-F2XXC5
In Commercial Distribution

  • 00628101545840 ()
HS-08UV-F2XXC5

  • General-gas low pressure tubing, reusable
8' HOSE ASMBLY US VAC F2*XX COND 1/4"
OHIO MEDICAL, LLC
HS-08UV-F2XXC4
In Commercial Distribution

  • 00628101545833 ()
HS-08UV-F2XXC4

  • General-gas low pressure tubing, reusable
08FT HS ASM US VAC F2*OM 1/4'' COND
OHIO MEDICAL, LLC
HS-08UV-F2OMC4
In Commercial Distribution

  • 00628101545826 ()
HS-08UV-F2OMC4

  • General-gas low pressure tubing, reusable
8' HOSE ASMBLY US VAC DM*XX COND 5/16"
OHIO MEDICAL, LLC
HS-08UV-DMXXC5
In Commercial Distribution

  • 00628101545819 ()
HS-08UV-DMXXC5

  • General-gas low pressure tubing, reusable
8' HOSE ASMBLY US VAC DH*XX COND 5/16"
OHIO MEDICAL, LLC
HS-08UV-DHXXC5
In Commercial Distribution

  • 00628101545802 ()
HS-08UV-DHXXC5

  • General-gas low pressure tubing, reusable
8FT HS ASM US VAC DH*XX 1/4'' COND
OHIO MEDICAL, LLC
HS-08UV-DHXXC4
In Commercial Distribution

  • 00628101545796 ()
HS-08UV-DHXXC4

  • General-gas low pressure tubing, reusable
8' HOSE ASMBLY US VAC DH*PM COND 1/4 MRI
OHIO MEDICAL, LLC
HS-08UV-DHPMC4M
In Commercial Distribution

  • 00628101545789 ()
HS-08UV-DHPMC4M

  • General-gas low pressure tubing, reusable
No Description
WEINMANN Emergency Medical Technology GmbH + Co. KG
36336
In Commercial Distribution

  • 04054685271619 ()


  • General-gas low pressure tubing, reusable
No Description
WEINMANN Emergency Medical Technology GmbH + Co. KG
36334
In Commercial Distribution

  • 04054685271602 ()


  • General-gas low pressure tubing, reusable
No Description
WEINMANN Emergency Medical Technology GmbH + Co. KG
36332
In Commercial Distribution

  • 04054685271596 ()


  • General-gas low pressure tubing, reusable
No Description
WEINMANN Emergency Medical Technology GmbH + Co. KG
36335
In Commercial Distribution

  • 04054685271589 ()


  • General-gas low pressure tubing, reusable
Low-pressure hoses are intended for the transfer of medical gases or vacuum, and/or the connection of two medical products (e.g. a pressure regulator with an emergency ventilator).
GCE, s.r.o.
0731003US
In Commercial Distribution

  • 08592346756885 ()


  • General-gas low pressure tubing, reusable
Rigid Gas Permeable Contact Lens
Bausch & Lomb Incorporated
itaflurofocon A
In Commercial Distribution

  • 00785811435622 ()
Boston Equalens

  • Rigid-gas-permeable corrective contact lens, extended-wear
InThrill Thrombectomy Catheter (AS-01312)
INARI MEDICAL INC
43-102
In Commercial Distribution

43-102

  • Electronic occlusion spectacles
No Description
ESAOTE SPA
229003500
In Commercial Distribution

  • 08056304452634 ()


  • MRI system coil, radio-frequency
No Description
BIOPRO, INC.
17650
In Commercial Distribution

  • 00810012483797 ()


  • Surgical drill guide, single-use
No Description
BIOPRO, INC.
17650
In Commercial Distribution

  • M209176500 ()


  • Surgical drill guide, reusable
No Description
BIOPRO, INC.
10723
In Commercial Distribution

  • M209107230 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
R.D.J. TOV IMPLANT LTD
11.4mm
In Commercial Distribution

  • 07290117801802 ()
PAS15S11

  • Dental implant system
No Description
R.D.J. TOV IMPLANT LTD
9mm
In Commercial Distribution

  • 07290117801758 ()
PAS15S

  • Dental implant system
Blister of 6 units
NUSMILE, LTD.
ZHEDST2115
In Commercial Distribution

  • 00810118100758 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZKFLEX2115
In Commercial Distribution

  • 00810118100499 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZKFILE3115
In Commercial Distribution

  • 00810118100406 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZKFILE2515
In Commercial Distribution

  • 00810118100284 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZKFILE2115
In Commercial Distribution

  • 00810118100161 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZHEDST3115
In Commercial Distribution

  • 00810118100970 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZHEDST2515
In Commercial Distribution

  • 00810118100864 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZKFLEX3115
In Commercial Distribution

  • 00810118100659 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZKFLEX2515
In Commercial Distribution

  • 00810118100574 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. The device is attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System. The design of the StabiliBase adapter can be especially suitable for deep tracheostomas.
Atos Medical AB
7289
In Commercial Distribution

  • 07331791016455 ()
  • 07331791008016 ()
  • 07331791017674 ()
7289

  • Removable ambulatory appliance skin-adherent patch
3 units
NUSMILE, LTD.
UDMO1504
In Commercial Distribution

  • 00810092938743 ()


  • Manual non-rotary dental instrument handle
No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
9mm
In Commercial Distribution

  • 07290018434635 ()
AA15

  • Dental implant system
Application for sending a live video stream from the medical operating theater to remote viewers. The class of HW devices with or without a touch panel display (TPD). It is used to connect to a video source and capture, archive and stream the video to the Orpheus System central server and over the multi-cast network to be viewed from the Orpheus Show application.
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025032 ()
MCU-EG00407

  • Electrosurgical system monitor/shield
GETINGE WD 15 CLARO, WASHER DISINFECTOR
Getinge Disinfection AB
GE15
In Commercial Distribution

  • 07340153700239 ()
GE15-003

  • Surgical utensil washer/disinfector
Negative Pressure Wound Therapy System / 087.4012
Medela AG
200.8589
In Commercial Distribution

  • 07612367053167 ()
  • 07612367089067 ()


  • Negative-pressure wound therapy system, electric, reusable
Negative Pressure Wound Therapy System / 087.4006
Medela AG
Invia Motion
Not in Commercial Distribution

  • 07612367045704 ()
  • 07612367045711 ()


  • Negative-pressure wound therapy system, electric, reusable
No Description
Ortoma AB (Publ)
1001
In Commercial Distribution

  • 07350137520647 ()
  • 07350137521125 ()
60-001

  • Electromagnetic/optical surgical navigation device tracking system
Kit Contains: CTF33, 11x100 Kii Fios ZTHR 6/BX CFF12, 5x100 Kii Fios ADVFIX DP 10/BX CFS02, 5x100 Kii SLEEVE ADVFIX 12/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK213
In Commercial Distribution

  • 20607915129402 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
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