Company Name Brand Name GMDN Term 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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Smoke Shark III Smoke Evacuator 220V-240V 50/60Hz
Conmed Corporation
SE03-220
In Commercial Distribution

  • 20845854600082 ()
  • 10845854600085 ()
SE03-220

  • Surgical plume evacuation system
Smoke evacuation system 220V for Ergon 2 and 3, includes pneumatic foot switch. Requires H8-300-41-A mounting bracket. AIR SAFE filters required and QUIKLINK automatic activation device sold separately.
SKYTRON LLC
ELVV220
In Commercial Distribution

  • 10841736114992 ()


  • Surgical plume evacuation system
Smoke Evacuation System for Models Ergon 2 and 3, includes pneumatic foot switch. Requires H8-300-41-A mounting bracket. AIR SAFE filters and QUIKLINK automatic activation device sold separately.
SKYTRON LLC
SMOKE-E-VAC
In Commercial Distribution

  • 10841736100810 ()
SMOKE-E-VAC

  • Surgical plume evacuation system
Automatic activation device for Smoke-e-vac
SKYTRON LLC
QUIKLINK
In Commercial Distribution

  • 10841736100773 ()
QUIKLINK

  • Surgical plume evacuation system
No Description
DIASORIN MOLECULAR LLC
MOL2500
In Commercial Distribution

  • 20816101025521 ()


  • Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Synapse Biomedical, Inc.
22-0009
In Commercial Distribution

  • 00852184003359 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
Implant Assembly/Packing block
SEASPINE ORTHOPEDICS CORPORATION
86-0070
In Commercial Distribution

  • 10889981127121 ()
86-0070

  • Bone graft packing block
Graft Packing Block 30mm x 24mm x XXmm
SEASPINE ORTHOPEDICS CORPORATION
93-6116
In Commercial Distribution

  • 10889981091392 ()

  • 30mm x 24mm x XXmm
93-6116

  • Bone graft packing block
Graft Packing Block, 26mm
SEASPINE ORTHOPEDICS CORPORATION
93-6115
In Commercial Distribution

  • 10889981091385 ()

  • 26mm
93-6115

  • Bone graft packing block
Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-3157
In Commercial Distribution

  • 10889981088309 ()
93-3157

  • Bone graft packing block
Pacifica-S Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-3156
In Commercial Distribution

  • 10889981088293 ()
93-3156

  • Bone graft packing block
Pacifica Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-3155
In Commercial Distribution

  • 10889981088286 ()
93-3155

  • Bone graft packing block
Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-4157
In Commercial Distribution

  • 10889981089917 ()
93-4157

  • Bone graft packing block
EVACUATOR, SAFTEVAC, 110 VOLT
DERMATOLOGIC LAB AND SUPPLY, INC.
EV-I
In Commercial Distribution

  • 00609960001302 ()
EV-I

  • Surgical plume evacuation system
SYNFIX® EVOLUTION IMPLANT PACKING STATION
SYNTHES (U.S.A.) LP
03.835.050
In Commercial Distribution

  • 07611819658172 ()
  • H981038350500 ()
  • 10705034814193 ()
03835050

  • Bone graft packing block
Stat Profile pHOx Ultra/CCX Control CO-Ox Tri Level L7, 8 ,9 (amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480491877 ()
  • 00385489491878 ()
49187

  • Assisted reproduction centrifuge tube
Stat Profile pHOx Ultra/CCX Control Chemistry L4, 5 (amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480491846 ()
  • 00385489491847 ()
49184

  • Assisted reproduction centrifuge tube
Stat Profile pHOx Ultra/CCX Blood Gas Controls Multipack L1, 2, 3 (Amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480489355 ()
  • 00385489489356 ()
48935

  • Assisted reproduction centrifuge tube
Surgical Smoke Plume Evacuator 100V-120V 50/60Hz
Conmed Corporation
PLVV120
In Commercial Distribution

  • 30845854061163 ()
PLVV120

  • Surgical plume evacuation system
COMPACTOR
SpineArt SA
SCA-IN 19 00-N
In Commercial Distribution

  • 07640185340862 ()
SCA-IN 19 00-N

  • Bone graft packing block
COMPACTION BASE
SpineArt SA
SCA-IN 07 00-N
In Commercial Distribution

  • 07640185340015 ()
SCA-IN 07 00-N

  • Bone graft packing block
Compaction base
SpineArt SA
SCA-IC 04 00-N
In Commercial Distribution

  • 07640151086435 ()
SCA-IC 04 00-N

  • Bone graft packing block
No Description
EDGE SYSTEMS LLC
10000
In Commercial Distribution

  • 00850043007067 ()
10000

  • Surgical plume evacuation system
SABER LUMBAR I/F CAGE SYSTEM BONE PACKING STAND
DEPUY SPINE, LLC
287006000
Not in Commercial Distribution

  • 10705034215716 ()
287006000

  • Bone graft packing block
The ReoAmbulator model is 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 ReoAmbulator 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
B
In Commercial Distribution

  • 07290017844305 ()
RA01-0000-00

  • Gait rehabilitation system harness
Graft Block
SEASPINE ORTHOPEDICS CORPORATION
36-90-3061
In Commercial Distribution

  • 10889981162368 ()
36-90-3061

  • Bone graft packing block
Graft Block
SEASPINE ORTHOPEDICS CORPORATION
TO2-006000
In Commercial Distribution

  • 10889981195755 ()
TO2-006000

  • Bone graft packing block
Graft Block
SEASPINE ORTHOPEDICS CORPORATION
TA2-006000
In Commercial Distribution

  • 10889981213022 ()
TA2-006000

  • Bone graft packing block
RC HS27 SV FROZEN CULT
DIAGNOSTIC HYBRIDS, INC.
F-87-0102-24
In Commercial Distribution

  • 30014613335818 ()
F-87-0102-24

  • Cell culture line IVD
RC MCCOY SV FROZEN CULT
DIAGNOSTIC HYBRIDS, INC.
F-54-0102-24
In Commercial Distribution

  • 30014613335801 ()
F-54-0102-24

  • Cell culture line IVD
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