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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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LEXO - 09120077180076

The LEXO is a mechatronic therapy system for body weight-supported gait rehabilitation of patients with a limited ability to walk.
tyromotion GmbH
R1
In Commercial Distribution

  • 09120077180076 ()


  • Treadmill/elliptical gait rehabilitation system

LEOPARD - 10705034212487

LEOPARD SYSTEM FILLER BLOCK
DEPUY SPINE, LLC
286409100
Not in Commercial Distribution

  • 10705034212487 ()
286409100

  • Bone graft packing block

LEG-UP - 05050962080065

LEG-UP
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LEG-UP YELLOW 26IN
In Commercial Distribution

  • 05050962080065 ()
HA0965

  • Movement-resistance gait rehabilitation device

LEG-UP - 05050962023048

LEG-UP
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LEG-UP BLACK 26IN
In Commercial Distribution

  • 05050962023048 ()
HA0970

  • Movement-resistance gait rehabilitation device

LEEP System 1000® Smoke Evacuation System - 00888937014440

LEEP System 1000® Smoke Evacuation System (110 VAC)
Coopersurgical, Inc.
6080-2
In Commercial Distribution

  • 00888937014440 ()


  • Surgical plume evacuation system

LEEP PRECISION™ Smoke Evacuation System - 00888937019940

LEEP PRECISION™ Smoke Evacuation System (120 VAC)
Coopersurgical, Inc.
DM53502
In Commercial Distribution

  • 00888937019940 ()


  • Surgical plume evacuation system

LEEP PRECISION™ Smoke Evacuation - 00888937014327

LEEP PRECISION™ Smoke Evacuation (120 VAC)
Coopersurgical, Inc.
53502
In Commercial Distribution

  • 00888937014327 ()


  • Surgical plume evacuation system

KODIAK PL TL GRAFT BLOCK - 00819824028691

The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6Al-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.
MET 1 TECHNOLOGIES, LLC
04-07G
In Commercial Distribution

  • 00819824028691 ()
04-07G

  • Bone graft packing block

KEEOGO - CLINICIAN KIT - 07540162060007

Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical

Jhane Barnes - 00715317534734

Origin Sand Spectacle
Kenmark Optical, Inc.
ORIGSA53
In Commercial Distribution

  • 00715317534734 ()


  • Prescription spectacles

Jhane Barnes - 00715317534727

Origin Sand Spectacle
Kenmark Optical, Inc.
ORIGSA51
In Commercial Distribution

  • 00715317534727 ()


  • Prescription spectacles

Jhane Barnes - 00715317534710

Origin Black Spectacle
Kenmark Optical, Inc.
ORIGBK53
In Commercial Distribution

  • 00715317534710 ()


  • Prescription spectacles

Jhane Barnes - 00715317534703

Origin Black Spectacle
Kenmark Optical, Inc.
ORIGBK51
In Commercial Distribution

  • 00715317534703 ()


  • Prescription spectacles

Jhane Barnes - 00715317534680

Origin Steel Spectacle
Kenmark Optical, Inc.
ORIGST51
In Commercial Distribution

  • 00715317534680 ()


  • Prescription spectacles

Jhane Barnes - 00715317534673

Origin Brown Spectacle
Kenmark Optical, Inc.
ORIGBR53
In Commercial Distribution

  • 00715317534673 ()


  • Prescription spectacles

Jhane Barnes - 00715317534666

Origin Brown Spectacle
Kenmark Optical, Inc.
ORIGBR51
In Commercial Distribution

  • 00715317534666 ()


  • Prescription spectacles

JULIET ® Ti LL Instrumentation - 07640185342989

Base
SpineArt SA
JLL-IN 44 00-N
In Commercial Distribution

  • 07640185342989 ()
JLL-IN 44 00-N

  • Bone graft packing block

JULIET ® INSTRUMENTATION - 07640178983052

ANGULATED IMPACTOR
SpineArt SA
JLL-IN 11 02-N
Not in Commercial Distribution

  • 07640178983052 ()
JLL-IN 11 02-N

  • Bone graft packing block

JULIET ® INSTRUMENTATION - 07640178982819

STRAIGHT IMPACTOR
SpineArt SA
JLL-IN 11 01-N
Not in Commercial Distribution

  • 07640178982819 ()
JLL-IN 11 01-N

  • Bone graft packing block

JULIET ® INSTRUMENTATION - 07640178981638

COMPACTION BASE
SpineArt SA
JUT-IN 00 01-N
Not in Commercial Distribution

  • 07640178981638 ()
JUT-IN 00 01-N

  • Bone graft packing block

JULIET INSTRUMENTATION - 07640151087098

COMPACTION BASE (JULIET LL-Instruments)
SpineArt SA
JUL-IN 01 00-N
In Commercial Distribution

  • 07640151087098 ()
JUL-IN 01 00-N

  • Bone graft packing block

JULIET INSTRUMENTATION - 07640151087050

COMPACTOR
SpineArt SA
JUL-IN 14 00-N
In Commercial Distribution

  • 07640151087050 ()
JUL-IN 14 00-N

  • Bone graft packing block

JULIET INSTRUMENTATION - 07640139349941

Compaction base
SpineArt SA
DYN-IP 01 03-N
In Commercial Distribution

  • 07640139349941 ()
DYN-IP 01 03-N

  • Bone graft packing block

JULIET INSTRUMENTATION - 07640139342881

Compaction base
SpineArt SA
DYN-IT 00 03-N
In Commercial Distribution

  • 07640139342881 ()
DYN-IT 00 03-N

  • Bone graft packing block

JULIET INSTRUMENTATION - 07640139342423

Compaction base
SpineArt SA
DYN-IP 00 03-N
In Commercial Distribution

  • 07640139342423 ()
DYN-IP 00 03-N

  • Bone graft packing block

JULIET INSTRUMENTATION - 07640139342416

Compactor
SpineArt SA
DYN-IP 00 02-N
In Commercial Distribution

  • 07640139342416 ()
DYN-IP 00 02-N

  • Bone graft packing block

JULIET INSTRUMENTATION - 07640178982765

COMPACTION BASE
SpineArt SA
JLL-IN 08 01-N
In Commercial Distribution

  • 07640178982765 ()
JLL-IN 08 01-N

  • Bone graft packing block

JBAIDS - 00851458005075

JBAIDS IVD Influenza A Subtyping Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0138
Not in Commercial Distribution

  • 00851458005075 ()
JRPD-ASY-0138

  • Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)

JAGUAR LUMBAR I/F CAGE - 10705034007038

JAGUAR LUMBAR I/F CAGE SYSTEM FILLER BLOCK
DEPUY SPINE, LLC
6000199
In Commercial Distribution

  • 10705034007038 ()
6000199

  • Bone graft packing block

Impulse Interbody Spacer System - 00842048137573

Packing Block
DEGEN MEDICAL, INC.
07-11M
In Commercial Distribution

  • 00842048137573 ()
07-11M

  • Bone graft packing block

INNESIS PEEK TL CAGE - 08809763504495

Bone Filler
BK MEDITECH CO.,LTD.
52865
In Commercial Distribution

  • 08809763504495 ()


  • Bone graft packing block

INNESIS PEEK CERVICAL CAGE - 08809763504426

Graft Case
BK MEDITECH CO.,LTD.
42640
In Commercial Distribution

  • 08809763504426 ()


  • Bone graft packing block

INNESIS PEEK CERVICAL CAGE - 08809763504761

Graft Case
BK MEDITECH CO.,LTD.
42645
In Commercial Distribution

  • 08809763504761 ()


  • Bone graft packing block

INNESIS PEEK CAGE - 08809763504204

Cage Support
BK MEDITECH CO.,LTD.
52750-10
In Commercial Distribution

  • 08809763504204 ()


  • Bone graft packing block

I/F CAGE - 10705034187969

CERVICAL I/F CAGE FILLER BLOCK
DEPUY SPINE, LLC
273301400
In Commercial Distribution

  • 10705034187969 ()
273301400

  • Bone graft packing block

Health o meter professional - 00851628008066

Eye Level Digital Scale, Origin USA
Pelstar, LLC
501KL
In Commercial Distribution

  • 00851628008066 ()


  • Stand-on floor scale, electronic

Healing Innovations - 00860003483206

robotic neurorehabilitation device for gait training and additional therapy purposes
Healing Innovations, Inc.
RWC1000
In Commercial Distribution

  • 00860003483206 ()


  • Gait rehabilitation frame, electric

Headstage Sterilization Tray - 07290114061216

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Headstage Sterilization Tray
In Commercial Distribution

  • 07290114061216 ()
366-000122-22

  • Depth electrode

Headstage Sterilization Net Tray - 07290114061193

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
1
In Commercial Distribution

  • 07290114061193 ()
366-000422-22

  • Depth electrode

HarmonyAIR - 00724995150129

The HarmonyAIR Smoke Evacuator Remote Switch Activator (RSA) is used with the HarmonyAIR Smoke Evacuation System.
STERIS CORPORATION
Smoke Evacuator Remote Switch Activator
Not in Commercial Distribution

  • 00724995150129 ()
QS0028

  • Surgical plume evacuation system
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