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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ITOTAL CR IPOLY XE LATERAL I INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000I13
In Commercial Distribution

  • M572RCR020000I131 ()

  • Patient Specific
RCR020000I

  • Tibial insert
N/A
Conformis, Inc.
RCR020000H13
Not in Commercial Distribution

  • M572RCR020000H131 ()

  • Patient Specific
RCR020000H

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL G INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000G13
In Commercial Distribution

  • M572RCR020000G131 ()

  • Patient Specific
RCR020000G

  • Tibial insert
N/A
Conformis, Inc.
RCR101111303
In Commercial Distribution

  • M572RCR1011113031 ()

  • Patient Specific
RCR1011113

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee tibia prosthesis, metallic
N/A
Conformis, Inc.
RCR101111302
Not in Commercial Distribution

  • M572RCR1011113021 ()

  • Patient Specific
RCR1011113

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee tibia prosthesis, metallic
N/A
Conformis, Inc.
RCR101111301
In Commercial Distribution

  • M572RCR1011113011 ()

  • Patient Specific
RCR1011113

  • Uncoated knee tibia prosthesis, metallic
  • Total knee prosthesis implantation guide-instrument kit
N/A
Conformis, Inc.
RCR101111201
In Commercial Distribution

  • M572RCR1011112011 ()

  • Patient Specific
RCR1011112

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee femur prosthesis, metallic
ITOTAL CR IPOLY XE LATERAL F INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000F13
In Commercial Distribution

  • M572RCR020000F131 ()

  • Patient Specific
RCR020000F

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL E INSERT KIT LEFT NO TRIAL
Conformis, Inc.
RCR020000E13
In Commercial Distribution

  • M572RCR020000E131 ()

  • Patient Specific
RCR020000E

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL D INSERT KIT LEFT NO TRIAL
Conformis, Inc.
RCR020000D13
In Commercial Distribution

  • M572RCR020000D131 ()

  • Patient Specific
RCR020000D

  • Tibial insert
N/A
Conformis, Inc.
RCR020000C13
In Commercial Distribution

  • M572RCR020000C131 ()

  • Patient Specific
RCR020000C

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL B INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000B13
In Commercial Distribution

  • M572RCR020000B131 ()

  • Patient Specific
RCR020000B

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL A INSERT KIT LEFT NO TRIAL
Conformis, Inc.
RCR020000A13
In Commercial Distribution

  • M572RCR020000A131 ()

  • Patient Specific
RCR020000A

  • Tibial insert
N/A
Conformis, Inc.
RCR010000K13
In Commercial Distribution

  • M572RCR010000K131 ()

  • Patient Specific
RCR010000K

  • Tibial insert
N/A
Conformis, Inc.
RCR010000J13
In Commercial Distribution

  • M572RCR010000J131 ()

  • Patient Specific
RCR010000J

  • Tibial insert
N/A
Conformis, Inc.
RCR010000I13
In Commercial Distribution

  • M572RCR010000I131 ()

  • Patient Specific
RCR010000I

  • Tibial insert
N/A
Conformis, Inc.
RCR010000H13
In Commercial Distribution

  • M572RCR010000H131 ()

  • Patient Specific
RCR010000H

  • Tibial insert
N/A
Conformis, Inc.
RCR010000G13
In Commercial Distribution

  • M572RCR010000G131 ()

  • Patient Specific
RCR010000G

  • Tibial insert
N/A
Conformis, Inc.
RCR010000F13
In Commercial Distribution

  • M572RCR010000F131 ()

  • Patient Specific
RCR010000F

  • Tibial insert
N/A
Conformis, Inc.
RCR010000E13
In Commercial Distribution

  • M572RCR010000E131 ()

  • Patient Specific
RCR010000E

  • Tibial insert
N/A
Conformis, Inc.
RCR010000D13
In Commercial Distribution

  • M572RCR010000D131 ()

  • Patient Specific
RCR010000D

  • Tibial insert
N/A
Conformis, Inc.
RCR010000C13
In Commercial Distribution

  • M572RCR010000C131 ()

  • Patient Specific
RCR010000C

  • Tibial insert
N/A
Conformis, Inc.
RCR010000B13
In Commercial Distribution

  • M572RCR010000B131 ()

  • Patient Specific
RCR010000B

  • Tibial insert
N/A
Conformis, Inc.
RCR010000A13
In Commercial Distribution

  • M572RCR010000A131 ()

  • Patient Specific
RCR010000A

  • Tibial insert
IDUO–TIBIAL TRAY KIT–LEFT or right MEDIAL or lateral
Conformis, Inc.
RBK101111302
In Commercial Distribution

  • M572RBK1011113021 ()

  • Patient Specific
RBK1011113

  • Bicompartmental knee prosthesis
N/A
Conformis, Inc.
RBK101111301
Not in Commercial Distribution

  • M572RBK1011113011 ()

  • Patient Specific
RBK1011113

  • Bicompartmental knee prosthesis
N/A
Conformis, Inc.
RBK101111202
Not in Commercial Distribution

  • M572RBK1011112021 ()

  • Patient Specific
RBK1011112

  • Bicompartmental knee prosthesis
No Description
Conformis, Inc.
RBK101111201
Not in Commercial Distribution

  • M572RBK1011112011 ()

  • Patient Specific
RBK1011112

  • Bicompartmental knee prosthesis
AirLife™ Infant Skin Temperature Probe, Single Patient Use (Lullaby™, Care Plus™)
AirLife Finland Oy
6600-0196-700
In Commercial Distribution

  • 20889483587888 ()
  • 10889483587881 ()
  • 30889483587885 ()
  • 10190752181199 ()
6600-0196-700

  • General-purpose patient temperature probe, single-use
AirLife™ Infant Skin Temperature Probe, Single Patient Use (Lullaby™, Care Plus™)
AirLife Finland Oy
6600-0208-700
In Commercial Distribution

  • 20889483587901 ()
  • 10889483587904 ()
  • 10190752181205 ()
6600-0208-700

  • General-purpose patient temperature probe, single-use
A combination of single-use products intended to attach the Sentec Sensors to conventional measurement sites, recommended for adult, pediatric and neonatal patients with sensitive/fragile skin.
SenTec AG
PAK-SF
Not in Commercial Distribution

  • 17640121880978 ()
  • 07640121880971 ()


  • Transcutaneous blood gas monitoring system
  • Transcutaneous blood gas monitor sensor
  • Pulse Co-oximeter probe, reusable
A combination of single-use products intended to attach the Sentec sensors to conventional measurement sites, recommended for adult, pediatric and neonatal patients with mature/intact skin
SenTec AG
PAK-MI
Not in Commercial Distribution

  • 17640121880961 ()
  • 07640121880964 ()


  • Transcutaneous blood gas monitoring system
  • Transcutaneous blood gas monitor sensor
  • Pulse Co-oximeter probe, reusable
This clear, amorphous antimicrobial wound gel is designed to provide a moist healing environment and to help control bioburden.
CP Skin Health Group, Inc.
02530
Not in Commercial Distribution

  • 00390205025305 ()
  • 10090205025301 ()


  • Wound hydrogel dressing, antimicrobial
This clear, amorphous antimicrobial wound gel is designed to provide a moist healing environment and to help control bioburden.
CP Skin Health Group, Inc.
02528
Not in Commercial Distribution

  • 10090205025288 ()
  • 00390205025282 ()


  • Wound hydrogel dressing, antimicrobial
No Description
CP Skin Health Group, Inc.
02526
Not in Commercial Distribution

  • 10090205025264 ()
  • 00390205025268 ()


  • Wound hydrogel dressing, antimicrobial
EltaMD® Dermal Wound Cleanser is intended for the removal of foreign material, such as debris and dirt, from dermal wounds.
CP Skin Health Group, Inc.
02531
In Commercial Distribution

  • 00090205025311 ()
  • 10090205025318 ()


  • Skin detergent
EltaMD Laser Enzyme Gel: is an enzyme-enhanced moisturizer that promotes skin recovery, moisturization, and comfort when used after non-ablative and mildly ablative procedures.
CP Skin Health Group, Inc.
02267
Not in Commercial Distribution

  • 10090205022676 ()
  • 00090205022679 ()


  • Wound hydrogel dressing, non-antimicrobial
No Description
CP Skin Health Group, Inc.
03900
In Commercial Distribution

  • 00827854009832 ()
  • 10827854009839 ()


  • Wound hydrogel dressing, antimicrobial
No Description
CP Skin Health Group, Inc.
04000
In Commercial Distribution

  • 00827854001119 ()
  • 10827854001116 ()


  • Wound hydrogel dressing, non-antimicrobial
SKIN PACK
Cardinal Health 200, LLC
SBA69SKDN4
In Commercial Distribution

  • 50197106714131 ()
  • 10197106714133 ()
SBA69SKDN4

  • General surgical procedure kit, non-medicated, single-use
SKIN PACK
Cardinal Health 200, LLC
SBA69SKDN5
In Commercial Distribution

  • 50197106725045 ()
  • 10197106725047 ()
SBA69SKDN5

  • General surgical procedure kit, non-medicated, single-use
SKIN PACK
Cardinal Health 200, LLC
SBA69SKDNA
In Commercial Distribution

  • 50197106357772 ()
  • 10197106357774 ()
SBA69SKDNA

  • General surgical procedure kit, non-medicated, single-use
SKIN PACK
Cardinal Health 200, LLC
SBA69SKDN1
In Commercial Distribution

  • 50197106552603 ()
  • 10197106552605 ()
SBA69SKDN1

  • General surgical procedure kit, non-medicated, single-use
SKIN PACK
Cardinal Health 200, LLC
SBA69SKDN3
In Commercial Distribution

  • 50197106589289 ()
  • 10197106589281 ()
SBA69SKDN3

  • General surgical procedure kit, non-medicated, single-use
SKIN PACK
Cardinal Health 200, LLC
SBA69SKDN2
In Commercial Distribution

  • 50197106589241 ()
  • 10197106589243 ()
SBA69SKDN2

  • General surgical procedure kit, non-medicated, single-use
SKIN, VICKERS
KLS-Martin L.P.
15-006-01-07
In Commercial Distribution

  • 00888118020185 ()

  • 17 CM


  • Soft-tissue surgical hook, reusable
SKIN, VICKERS
KLS-Martin L.P.
15-001-18-07
In Commercial Distribution

  • 00888118020178 ()

  • 18.5 CM


  • Soft-tissue surgical hook, reusable
Skin Retractor
Avalign Technologies, Inc.
VM29-4252
In Commercial Distribution

  • 00190776040703 ()


  • Hand-held surgical retractor, reusable
Skin Retractor
Avalign Technologies, Inc.
VM29-4251
In Commercial Distribution

  • 00190776040697 ()


  • Hand-held surgical retractor, reusable
Skin Retractor
Avalign Technologies, Inc.
0-52417
In Commercial Distribution

  • 00190776161552 ()


  • Hand-held surgical retractor, reusable
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