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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Attachment Head B2
IPG Medical Corporation
MD2300F-002247
In Commercial Distribution

  • 00810071230585 ()


  • Musculoskeletal/physical therapy laser, professional
Attachment Head C
IPG Medical Corporation
MD2300F-002246
In Commercial Distribution

  • 00810071230578 ()


  • Musculoskeletal/physical therapy laser, professional
Attachment Head B1
IPG Medical Corporation
MD2300F-002244
In Commercial Distribution

  • 00810071230554 ()


  • Musculoskeletal/physical therapy laser, professional
Universal Stage One Handpiece
IPG Medical Corporation
MD2300F-001754
In Commercial Distribution

  • 00810071230547 ()


  • Musculoskeletal/physical therapy laser, professional
KIT, BABY CARE NORTHSIDE 1/EA, 40/CS
Asp Global, LLC
NSBK001
In Commercial Distribution

  • 00840216108226 ()
  • 10840216108223 ()


  • Infant care kit
FallGuard CordLess monitor with Infra-Red Motion Sensor
Smart Caregiver Corporation
GPIR1-SYS
In Commercial Distribution

  • 00812293011690 ()


  • Nurse call system alarm
Two Port Controller for Infrared Phototherapy Device
HEALTHLIGHT LLC
HL-C2J
In Commercial Distribution

  • 00858935006679 ()
502054

  • Musculoskeletal infrared phototherapy unit, non-wearable
Two Port 'In-line' Controller, Infrared Phototherapy Device
HEALTHLIGHT LLC
HL-C2
In Commercial Distribution

  • 00858935006594 ()
502045

  • Musculoskeletal infrared phototherapy unit, non-wearable
132-LED Blue/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-132B
In Commercial Distribution

  • 00858935006518 ()
602024

  • Musculoskeletal infrared phototherapy unit, non-wearable
264-LED Blue/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-264B
In Commercial Distribution

  • 00858935006488 ()
602021

  • Musculoskeletal infrared phototherapy unit, non-wearable
64-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-64R
In Commercial Distribution

  • 00858935006457 ()
602018

  • Musculoskeletal infrared phototherapy unit, non-wearable
264-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-264R
In Commercial Distribution

  • 00858935006419 ()
602014

  • Musculoskeletal infrared phototherapy unit, non-wearable
180-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-180R
In Commercial Distribution

  • 00858935006402 ()
602013

  • Musculoskeletal infrared phototherapy unit, non-wearable
132-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-132R
In Commercial Distribution

  • 00858935006396 ()
602012

  • Musculoskeletal infrared phototherapy unit, non-wearable
90-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-90R
In Commercial Distribution

  • 00858935006389 ()
602011

  • Musculoskeletal infrared phototherapy unit, non-wearable
Foot and Calf Pad, Infrared Phototherapy Unit
HEALTHLIGHT LLC
HL-NP
In Commercial Distribution

  • 00858935006266 ()
502032

  • Musculoskeletal infrared phototherapy unit, non-wearable
Foot and Ankle Pad, Infrared Phototherapy Unit
HEALTHLIGHT LLC
HL-PB
In Commercial Distribution

  • 00858935006068 ()
502006

  • Musculoskeletal infrared phototherapy unit, non-wearable
PILLOW SPEAKER, ELITE INFRARED, WESTCOM, 12 PIN,
Crest Healthcare Supply
XTWCCCEIXXXXTAAYL
In Commercial Distribution

  • B484XTWCCCEIXXXXTAAYL0 ()

  • Length: 8 Feet
  • Length: 10 Feet


  • Nurse call system
No Description
Biomet Orthopedics, LLC
110046598
In Commercial Distribution

  • 00887868555732 ()

  • PATIENT MATCHED
110046598

  • Custom-made organ/bone anatomy model/surgical guide kit
No Description
Biomet Orthopedics, LLC
110031178
In Commercial Distribution

  • 00880304818965 ()

  • Patient Matched
110031178

  • Custom-made organ/bone anatomy model/surgical guide kit
No Description
Biomet Orthopedics, LLC
110019066
In Commercial Distribution

  • 00880304818958 ()

  • Patient Matched
110019066

  • Custom-made organ/bone anatomy model/surgical guide kit
No Description
Biomet Orthopedics, LLC
110027735
In Commercial Distribution

  • 00880304818941 ()

  • PATIENT MATCHED
110027735

  • Reverse shoulder prosthesis base plate
No Description
Biomet Orthopedics, LLC
110027734
In Commercial Distribution

  • 00880304818934 ()

  • PATIENT MATCHED
110027734

  • Reverse shoulder prosthesis base plate
N/A
Conformis, Inc.
HAA050D00101
Not in Commercial Distribution

  • M572HAA050D001011 ()

  • Patient Specific
HAA050D001

  • Joint prosthesis implantation kit, single-use
N/A
Conformis, Inc.
HCC032000001
Not in Commercial Distribution

  • M572HCC0320000011 ()

  • Patient Specific
HCC0320000

  • Metallic acetabulum prosthesis
HIP-PATIENT SPECIFIC STEM LEFT
Conformis, Inc.
HBS033000001
In Commercial Distribution

  • M572HBS0330000011 ()

  • Patient Specific
HBS0330000

  • Uncoated femoral stem prosthesis, one-piece
N/A
Conformis, Inc.
BKA111111101
Not in Commercial Distribution

  • M572BKA1111111011 ()

  • Patient Specific
BKA1111111

  • Bicompartmental knee prosthesis
N/A
Conformis, Inc.
UKA111111101
Not in Commercial Distribution

  • M572UKA1111111011 ()

  • Patient Specific
UKA1111111

  • Unicondylar knee prosthesis
iTotal® Posterior Stabilized (PS) Knee Replacement System
Conformis, Inc.
TPS111111102
In Commercial Distribution

  • M572TPS1111111021 ()

  • Patient Specific
TPS1111111

  • Total knee prosthesis implantation guide-instrument kit
  • Posterior-stabilized total knee prosthesis
ITOTAL IDENTITY PS FEMORAL IMPLANT (COCR, CEMENTED), RIGHT or left
Conformis, Inc.
TPS-101-111211
In Commercial Distribution

  • M572TPS1011112111 ()

  • Patient specific
TPS-101-1112

  • Uncoated knee femur prosthesis, metallic
ITOTAL PS–IPOLY XE–IMPLANT KIT–LEFT or right
Conformis, Inc.
TPS121111102
In Commercial Distribution

  • M572TPS1211111021 ()

  • Patient Specific
TPS1211111

  • Total knee prosthesis implantation guide-instrument kit
  • Posterior-stabilized total knee prosthesis
PS JIGS, LEFT AND RIGHT
Conformis, Inc.
TPS000D00201
In Commercial Distribution

  • M572TPS000D002011 ()

  • Patient Specific
TPS-000-D002

  • Total knee prosthesis implantation guide-instrument kit
ITOTAL CR-IPOLY XE-IMPLANT KIT HYBRID-LEFT or right
Conformis, Inc.
TCR121SPEC02
In Commercial Distribution

  • M572TCR121SPEC021 ()

  • Patient Specific
TCR121SPEC

  • Total knee prosthesis implantation guide-instrument kit
  • Cruciate-retaining total knee prosthesis
N/A
Conformis, Inc.
TCR121111102
In Commercial Distribution

  • M572TCR1211111021 ()

  • Patient Specific
TCR1211111

  • Total knee prosthesis implantation guide-instrument kit
  • Cruciate-retaining total knee prosthesis
ITOTAL CR ? IPOLY XE ? IMPLANT KIT UNCAPTURED - LEFT or right
Conformis, Inc.
TCR121111101
In Commercial Distribution

  • M572TCR1211111011 ()

  • Patient Specific
TCR1211111

  • Total knee prosthesis implantation guide-instrument kit
  • Cruciate-retaining total knee prosthesis
N/A
Conformis, Inc.
TCR111SPEC02
In Commercial Distribution

  • M572TCR111SPEC021 ()

  • Patient Specific
TCR111SPEC

  • Total knee prosthesis implantation guide-instrument kit
  • Cruciate-retaining total knee prosthesis
N/A
Conformis, Inc.
TCR111111102
In Commercial Distribution

  • M572TCR1111111021 ()

  • Patient Specific
TCR1111111

  • Total knee prosthesis implantation guide-instrument kit
  • Cruciate-retaining total knee prosthesis
N/A
Conformis, Inc.
TCR111111101
In Commercial Distribution

  • M572TCR1111111011 ()

  • Patient Specific
TCR1111111

  • Total knee prosthesis implantation guide-instrument kit
  • Cruciate-retaining total knee prosthesis
ITOTAL IDENTITY CR FEMORAL IMPLANT (COCR, CEMENTED), LEFT or right
Conformis, Inc.
TCR-101-111211
In Commercial Distribution

  • M572TCR1011112111 ()

  • patient specific
TCR-101-1112

  • Uncoated knee femur prosthesis, metallic
iTotal® Posterior Stabilized (PS) Knee Tibial Kit
Conformis, Inc.
RPS101111302
In Commercial Distribution

  • M572RPS1011113021 ()

  • Patient Specific
RPS1011113

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee tibia prosthesis, metallic
N/A
Conformis, Inc.
RPS101111301
In Commercial Distribution

  • M572RPS1011113011 ()

  • Patient Specific
RPS1011113

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee tibia prosthesis, metallic
iTotal® Posterior Stabilized (PS) Knee Tibial Kit
Conformis, Inc.
RPS101111202
In Commercial Distribution

  • M572RPS1011112021 ()

  • Patient Specific
RPS1011112

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee femur prosthesis, metallic
N/A
Conformis, Inc.
RPS101111201
In Commercial Distribution

  • M572RPS1011112011 ()

  • Patient Specific
RPS1011112

  • Total knee prosthesis implantation guide-instrument kit
  • Uncoated knee femur prosthesis, metallic
CR JIGS, LEFT AND RIGHT
Conformis, Inc.
TCR000D00201
In Commercial Distribution

  • M572TCR000D002011 ()

  • Patient Specific
TCR-000-D002

  • Total knee prosthesis implantation guide-instrument kit
N/A
Conformis, Inc.
RUK101111302
In Commercial Distribution

  • M572RUK1011113021 ()

  • Patient Specific
RUK1011113

  • Uncoated unicondylar knee tibia prosthesis, metallic
N/A
Conformis, Inc.
RUK101111301
Not in Commercial Distribution

  • M572RUK1011113011 ()

  • Patient Specific
RUK1011113

  • Uncoated unicondylar knee femur prosthesis
N/A
Conformis, Inc.
RUK101111203
In Commercial Distribution

  • M572RUK1011112031 ()

  • Patient Specific
RUK1011112

  • Uncoated unicondylar knee femur prosthesis
N/A
Conformis, Inc.
RUK101111202
In Commercial Distribution

  • M572RUK1011112021 ()

  • Patient Specific
RUK1011112

  • Uncoated unicondylar knee femur prosthesis
ITOTAL CR IPOLY XE LATERAL K INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000K13
In Commercial Distribution

  • M572RCR020000K131 ()

  • Patient Specific
RCR020000K

  • Tibial insert
ITOTAL CR IPOLY XE LATERAL J INSERT KIT LEFT or right NO TRIAL
Conformis, Inc.
RCR020000J13
In Commercial Distribution

  • M572RCR020000J131 ()

  • Patient Specific
RCR020000J

  • Tibial insert
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