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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Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D14mm A3.5
In Commercial Distribution

  • D960BPMA5141 ()
30112203

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D14mm A4
In Commercial Distribution

  • D960BPMA4141 ()
30112204

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D14mm A3
In Commercial Distribution

  • D960BPMA3141 ()
30112202

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D14mm A2
In Commercial Distribution

  • D960BPMA2141 ()
30112201

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D14mm A1
In Commercial Distribution

  • D960BPMA1141 ()
30112200

  • Dental appliance fabrication material, ceramic
Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical
Mobility Assist
BIODEX MEDICAL SYSTEMS, INC.
950-570
In Commercial Distribution

  • 00718175005705 ()
950-570

  • Gait rehabilitation electronic walker
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
NxSTEP Unweighing System
BIODEX MEDICAL SYSTEMS, INC.
945-480
In Commercial Distribution

  • 00718175004807 ()
945-480

  • Mobile gait rehabilitation system, harness-support
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)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0120
Not in Commercial Distribution

  • 00815381020147 ()
RFIT-ASY-0120

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Vector Gait and Safety System, Base Model
BIONESS INC.
VEC-3000
In Commercial Distribution

  • 00815962020283 ()


  • Gait rehabilitation frame, manual
Vector Trolley Assembly, Elite Model
BIONESS INC.
VEC-1100
In Commercial Distribution

  • 00815962020276 ()


  • Gait rehabilitation frame, electric
Vector Gait and Safety System
BIONESS INC.
VEC-1000
In Commercial Distribution

  • 00815962020269 ()


  • Gait rehabilitation frame, electric
Graft Case
BK MEDITECH CO.,LTD.
42645
In Commercial Distribution

  • 08809763504761 ()


  • Bone graft packing block
Bone Filler
BK MEDITECH CO.,LTD.
52865
In Commercial Distribution

  • 08809763504495 ()


  • Bone graft packing block
Graft Case
BK MEDITECH CO.,LTD.
42640
In Commercial Distribution

  • 08809763504426 ()


  • Bone graft packing block
Cage Support
BK MEDITECH CO.,LTD.
52750-10
In Commercial Distribution

  • 08809763504204 ()


  • Bone graft packing block
Bone Condenser 8/9
BLUE SKY BIO LLC
STPCND89
In Commercial Distribution

  • 00810060223123 ()


  • Bone graft packing block
Bone Condenser 6/7
BLUE SKY BIO LLC
STPCND67
In Commercial Distribution

  • 00810060223109 ()


  • Bone graft packing block
Bone Condenser 4/5
BLUE SKY BIO LLC
STPCND45
In Commercial Distribution

  • 00810060223093 ()


  • Bone graft packing block
Bone Condenser 2/3
BLUE SKY BIO LLC
STPCND23
In Commercial Distribution

  • 00810060223086 ()


  • Bone graft packing block
Bone Condenser 10/11
BLUE SKY BIO LLC
STPCND1011
In Commercial Distribution

  • 00810060223079 ()


  • Bone graft packing block
BOVIE EZ LINK
BOVIE MEDICAL CORPORATION
SERS2
In Commercial Distribution

  • 10607151008496 ()
SERS2

  • Surgical plume evacuation system
SMOKE SHARK II 120V-220V - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
SE02-220
In Commercial Distribution

  • 10607151008304 ()
SE02-220

  • Surgical plume evacuation system
SMOKE SHARK II 120 V - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
SE02
In Commercial Distribution

  • 10607151008298 ()
SE02

  • Surgical plume evacuation system
PNEUMATIC FOOTSWITCH - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
FSSEP
In Commercial Distribution

  • 10607151004801 ()
FSSEP

  • Surgical plume evacuation system
SMOKE EVACUATOR ARTICULATED, ARMSTAND WITH FASTENERS
BOVIE MEDICAL CORPORATION
SEAS
In Commercial Distribution

  • 10607151065161 ()
SEAS

  • Surgical plume evacuation system
No Description
Bird & Cronin, LLC
08146545
In Commercial Distribution

  • 50610570149945 ()
  • 00610570149940 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08140780
In Commercial Distribution

  • 50610570004046 ()
  • 00610570004041 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08140680
In Commercial Distribution

  • 50610570003612 ()
  • 00610570003617 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08141082
In Commercial Distribution

  • 00610570187317 ()
  • 00610570005000 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08140722
In Commercial Distribution

  • 00610570187300 ()
  • 00610570003785 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08140602
In Commercial Distribution

  • 00610570187294 ()
  • 00610570003235 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08140542
In Commercial Distribution

  • 00610570187287 ()
  • 00610570003037 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08140452
In Commercial Distribution

  • 00610570187270 ()
  • 00610570002603 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
90000108
In Commercial Distribution

  • 00610570163250 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08146882
In Commercial Distribution

  • 00610570022823 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08146722
In Commercial Distribution

  • 00610570022618 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08146602
In Commercial Distribution

  • 00610570022335 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08146452
In Commercial Distribution

  • 00610570021918 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08140480
In Commercial Distribution

  • 00610570002801 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08146542
In Commercial Distribution

  • 00610570022236 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08141349
In Commercial Distribution

  • 00610570006120 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08141340
In Commercial Distribution

  • 00610570006113 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08141339
In Commercial Distribution

  • 00610570006106 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08140580
In Commercial Distribution

  • 00610570003136 ()


  • Gait rehabilitation system harness
No Description
Brainlab AG
2.3.1
Not in Commercial Distribution

  • 04056481132453 ()
25100-12A

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
2.3
Not in Commercial Distribution

  • 04056481006662 ()
25100-12

  • Radiology picture archiving and communication system workstation
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