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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No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1609
In Commercial Distribution

  • 09348215039776 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1509
In Commercial Distribution

  • 09348215039769 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1409
In Commercial Distribution

  • 09348215039752 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1309
In Commercial Distribution

  • 09348215039745 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1209
In Commercial Distribution

  • 09348215039738 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1109
In Commercial Distribution

  • 09348215039721 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1009
In Commercial Distribution

  • 09348215039714 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0909
In Commercial Distribution

  • 09348215039707 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0809
In Commercial Distribution

  • 09348215039691 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0609
In Commercial Distribution

  • 09348215039684 ()


  • Orthopaedic broach
The Optimal-G is a robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The Optimal-G enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
A
In Commercial Distribution

  • 07290017844312 ()
OG01-0000-01

  • Gait rehabilitation system harness
PsiF Post Packer (Long Impactor) Instrument
OMNIA MEDICAL, LLC
01-01-0010
In Commercial Distribution

  • 00843511100636 ()
01-01-0010

  • Bone graft packing block
The OMEGO is a robotic pre-gait therapy system for the rehabilitation of patients with neurologic disorders.
tyromotion GmbH
1
In Commercial Distribution

  • 09120077180083 ()


  • Treadmill/elliptical gait rehabilitation system
OCELOT STACKABLE CAGE SYSTEM FILLER BLOCK
DEPUY SPINE, LLC
273400900
In Commercial Distribution

  • 10705034189727 ()
273400900

  • Bone graft packing block
NxSTEP Unweighing System
BIODEX MEDICAL SYSTEMS, INC.
945-480
In Commercial Distribution

  • 00718175004807 ()
945-480

  • Mobile gait rehabilitation system, harness-support
NxSTEP Unweighing System, 115VAC
BIODEX MEDICAL SYSTEMS, INC.
950-485
In Commercial Distribution

  • 00718175004852 ()
950-485

  • Mobile gait rehabilitation system, harness-support
NxSTEP Unweighing System, without Harness
BIODEX MEDICAL SYSTEMS, INC.
950-484
In Commercial Distribution

  • 00718175004845 ()
950-484

  • Mobile gait rehabilitation system, harness-support
TLIF Bone Packing Block
Medyssey Co., Ltd.
NTPB-001
In Commercial Distribution

  • 08800048410296 ()


  • Bone graft packing block
Platform - W11 (Dynamic/Varian&EP)
Medyssey Co., Ltd.
NDPF-001
In Commercial Distribution

  • 08800048402215 ()


  • Bone graft packing block
Packing Block(C7)
Medyssey Co., Ltd.
N7PB-001
In Commercial Distribution

  • 08800048404127 ()


  • Bone graft packing block
Platform
Medyssey Co., Ltd.
NAPF-001
In Commercial Distribution

  • 08800042415952 ()


  • Bone graft packing block
MODIFIED INSTRUMENT FILLER BLOCK
DEPUY SPINE, LLC
698335436
In Commercial Distribution

  • 10705034371184 ()
698335436

  • Bone graft packing block
UNIVERSAL INSTRUMENTS FILLER BLOCK
DEPUY SPINE, LLC
273310200
In Commercial Distribution

  • 10705034188034 ()
273310200

  • Bone graft packing block
MODIFIED INSTRUMENT PACKING BLOCK
DEPUY SPINE, LLC
698344404
In Commercial Distribution

  • 10705034567648 ()
698344404

  • Bone graft packing block
PACKING BLOCK FOR ZERO-P IMPLANTS
Synthes GmbH
03.617.984
In Commercial Distribution

  • 07611819969780 ()
  • H981036179840 ()
  • 10705034717388 ()
03617984

  • Bone graft packing block
GRAFT PACKING BLOCK
Synthes GmbH
03.841.055
In Commercial Distribution

  • 07611819473140 ()
  • H981038410550 ()
  • 10705034732350 ()
03841055

  • Bone graft packing block
ACF GRAFT PACKING BLOCK
Synthes GmbH
396.996
In Commercial Distribution

  • H9813969960 ()
  • 10705034778204 ()
396996

  • Bone graft packing block
MODIFIED INSTRUMENT BONE GRAFT SLIDE
DEPUY SPINE, LLC
698341734
In Commercial Distribution

  • 10705034480749 ()
698341734

  • Bone graft packing block
STATION EX0516086 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0516086
In Commercial Distribution

  • 00643169793934 ()


  • Bone graft packing block
BLOCK EX0815056 LOADING 5 6 7 8MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0815056
In Commercial Distribution

  • 00643169671942 ()


  • Bone graft packing block
PACKING STATION EX0315064 CR GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0315064
In Commercial Distribution

  • 00643169631007 ()


  • Bone graft packing block
LID 7426010 PACKING FIXTURE
MEDTRONIC SOFAMOR DANEK, INC.
7426010
In Commercial Distribution

  • 00643169572645 ()


  • Bone graft packing block
FIXTURE 7426009 IMPLANT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
7426009
In Commercial Distribution

  • 00643169572638 ()


  • Bone graft packing block
Incision Locator
GLOBUS MEDICAL, INC.
675.404
In Commercial Distribution

  • 00849044042283 ()


  • Cardiovascular patch, animal-derived
Gait Trainer
RIFTON EQUIPMENT
K610
In Commercial Distribution

  • 00850001752237 ()


  • Gait rehabilitation frame, manual
The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients.
MiE medical imaging electronics GmbH
PICOLA-SCINTRON
In Commercial Distribution

  • 04260484140074 ()


  • Stationary gamma camera system
The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients.
MiE medical imaging electronics GmbH
SYNGULA-SCINTRON
In Commercial Distribution

  • 04260484140043 ()


  • Stationary gamma camera system
Graft Block
SEASPINE ORTHOPEDICS CORPORATION
RA2-006003
In Commercial Distribution

  • 10889981216535 ()
RA2-006003

  • Bone graft packing block
STATION X1213073 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
X1213073
In Commercial Distribution

  • 00643169448155 ()


  • Bone graft packing block
STATION X1213075 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
X1213075
In Commercial Distribution

  • 00643169445116 ()


  • Bone graft packing block
STATION X1213074 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
X1213074
In Commercial Distribution

  • 00643169445109 ()


  • Bone graft packing block
GUN EX1112020 GRAFT DELIVERY
MEDTRONIC SOFAMOR DANEK, INC.
EX1112020
In Commercial Distribution

  • 00643169293892 ()


  • Bone graft packing block
POSITIONER EX0512197 LARGE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0512197
In Commercial Distribution

  • 00643169181526 ()


  • Bone graft packing block
HOLDER EX0411338 FACET GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0411338
In Commercial Distribution

  • 00643169013285 ()


  • Bone graft packing block
LOADING BLOCK EX0311357 PSR CAGE
MEDTRONIC SOFAMOR DANEK, INC.
EX0311357
In Commercial Distribution

  • 00643169021280 ()


  • Bone graft packing block
IMPACTOR EX0711465 ANGLED GRAFT W/ TAB
MEDTRONIC SOFAMOR DANEK, INC.
EX0711465
In Commercial Distribution

  • 00643169050709 ()


  • Bone graft packing block
PACKING EX0112072 40-45-50-55GRAFT STATN
MEDTRONIC SOFAMOR DANEK, INC.
EX0112072
In Commercial Distribution

  • 00643169149663 ()


  • Bone graft packing block
PACKING EX0112070 22-26-32-36GRAFT STATN
MEDTRONIC SOFAMOR DANEK, INC.
EX0112070
In Commercial Distribution

  • 00643169149656 ()


  • Bone graft packing block
PACKING EX0112069 25-30-36 GRAFT STATION
MEDTRONIC SOFAMOR DANEK, INC.
EX0112069
In Commercial Distribution

  • 00643169149649 ()


  • Bone graft packing block
POSITIONER EX0911187 NO-STOP
MEDTRONIC SOFAMOR DANEK, INC.
EX0911187
In Commercial Distribution

  • 00643169089174 ()


  • Bone graft packing block
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