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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LEGION TIB CONE ID 28 LONG
Smith & Nephew, Inc.
71935398
In Commercial Distribution

  • 00885556645505 ()
71935398

  • Knee arthroplasty wedge
LEGION TIBIA CONE ID 28 SHORT
Smith & Nephew, Inc.
71935391
In Commercial Distribution

  • 00885556645437 ()
71935391

  • Knee arthroplasty wedge
SEC MAND BIC BD SZ 28
Rmo, Inc.
B00758
In Commercial Distribution

  • 00000008857972 ()
  • 00885797092731 ()


  • Orthodontic metal band
36"" X 28"" FLUORO COVER, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426015929 ()
  • 00748426015924 ()


  • Instrument/equipment drape, single-use, sterile
OPTIFIX XLPE ANTVTD 28 +4 50-54
Smith & Nephew, Inc.
71337850
In Commercial Distribution

  • 00885556021910 ()
71337850

  • Non-constrained polyethylene acetabular liner
OPTIFIX XLPE ANTVTD 28 +4 56-62
Smith & Nephew, Inc.
71337856
In Commercial Distribution

  • 00885556020036 ()
71337856

  • Non-constrained polyethylene acetabular liner
HXLPE MH/28 10° Oblique Liner
MAXX ORTHOPEDICS, INC.
MO-MLJD-MH/28
In Commercial Distribution

  • 00840333903056 ()


  • Metal-on-polyethylene total hip prosthesis
HXLPE MF/28 10° Oblique Liner
MAXX ORTHOPEDICS, INC.
MO-MLJD-MF/28
In Commercial Distribution

  • 00840333903025 ()


  • Metal-on-polyethylene total hip prosthesis
HXLPE MD/28 10° Oblique Liner
MAXX ORTHOPEDICS, INC.
MO-MLJD-MD/28
In Commercial Distribution

  • 00840333903001 ()


  • Metal-on-polyethylene total hip prosthesis
HXLPE MB/28 10° Oblique Liner
MAXX ORTHOPEDICS, INC.
MO-MLJD-MB/28
In Commercial Distribution

  • 00840333902998 ()


  • Metal-on-polyethylene total hip prosthesis
TITANIUM LOCK NUTS, 28 THREAD TYPE
PMT CORPORATION
1201-32
In Commercial Distribution

  • 10650551093609 ()
  • 00650551093602 ()

  • Lumen/Inner Diameter: 0.25 Inch
1201-32

  • Cervical spine immobilization system, single-use
InCORPorate VBR Implant 33 W x 28 L x 28 H mm 10 degree Lordotic
SPINAL ELEMENTS
104-1-33282810
In Commercial Distribution

  • 00840916125561 ()


  • Polymeric spinal interbody fusion cage
Qty 1 - 15610003 - Emerald S Scanner (US) Qty 1 - 15600141 - Emerald S Scanner Accessories Qty 1 - 15693001 Cariosity Tip
D4D TECHNOLOGIES, LLC
15600140 Emerald S Scanner Kit, Cariosity, US
Not in Commercial Distribution

  • 00858809006170 ()
  • 00858809006224 ()


  • Dental caries detector, optical induced fluorescence
  • Dental milling system, CAD/CAM, chairside
No Description
NINEPOINT MEDICAL, INC.
95501-20
In Commercial Distribution

  • 00859591006201 ()

  • Outer Diameter: 2.7 Millimeter
95501-20

  • Endoscopic optical coherence tomography system probe
No Description
NINEPOINT MEDICAL, INC.
95501-14
In Commercial Distribution

  • 00859591006195 ()

  • Outer Diameter: 2.7 Millimeter
95501-14

  • Endoscopic optical coherence tomography system probe
No Description
NINEPOINT MEDICAL, INC.
95501-LP
In Commercial Distribution

  • 00859591006188 ()

  • Outer Diameter: 2.7 Millimeter
95501-LP

  • Endoscopic optical coherence tomography system probe
No Description
NINEPOINT MEDICAL, INC.
95101-14C
In Commercial Distribution

  • 00859591006171 ()

  • Outer Diameter: 14 Millimeter
95101-14C

  • Endoscopic optical coherence tomography system probe
No Description
NINEPOINT MEDICAL, INC.
95101-20C
In Commercial Distribution

  • 00859591006164 ()

  • Outer Diameter: 20 Millimeter
95101-20C

  • Endoscopic optical coherence tomography system probe
No Description
NINEPOINT MEDICAL, INC.
95101-17C
In Commercial Distribution

  • 00859591006157 ()

  • Outer Diameter: 17 Millimeter
95101-17C

  • Endoscopic optical coherence tomography system probe
No Description
NINEPOINT MEDICAL, INC.
95301-M-14C
In Commercial Distribution

  • 00859591006140 ()

  • Outer Diameter: 14 Millimeter
95301-M-14C

  • Endoscopic optical coherence tomography system probe
No Description
NINEPOINT MEDICAL, INC.
95301-M-20C
In Commercial Distribution

  • 00859591006133 ()

  • Outer Diameter: 20 Millimeter
95301-M-20C

  • Endoscopic optical coherence tomography system probe
No Description
NINEPOINT MEDICAL, INC.
95301-M-17C
In Commercial Distribution

  • 00859591006126 ()

  • Outer Diameter: 17 Millimeter
95301-M-17C

  • Endoscopic optical coherence tomography system probe
No Description
NINEPOINT MEDICAL, INC.
95301-M-17
In Commercial Distribution

  • 00859591006065 ()

  • Outer Diameter: 17 Millimeter
95301-M-17

  • Endoscopic optical coherence tomography system probe
No Description
NINEPOINT MEDICAL, INC.
95301-M-14
In Commercial Distribution

  • 00859591006058 ()

  • Outer Diameter: 14 Millimeter
95301-M-14

  • Endoscopic optical coherence tomography system probe
No Description
NINEPOINT MEDICAL, INC.
95101-20
In Commercial Distribution

  • 00859591006041 ()

  • Outer Diameter: 20 Millimeter
95101-20

  • Endoscopic optical coherence tomography system probe
No Description
NINEPOINT MEDICAL, INC.
95101-17
In Commercial Distribution

  • 00859591006034 ()

  • Outer Diameter: 17 Millimeter
95101-17

  • Endoscopic optical coherence tomography system probe
No Description
NINEPOINT MEDICAL, INC.
95101-14
In Commercial Distribution

  • 00859591006027 ()

  • Outer Diameter: 14 Millimeter
95101-14

  • Endoscopic optical coherence tomography system probe
The symphonX™ Handle with ratchet is for use in combination with the symphonX™ Instruments of the types: Grasper (short), Maryland (short), Scissors (short) and Clip Applier (short).
Fortimedix Surgical B.V.
Handle with ratchet
Not in Commercial Distribution

  • 08719324463096 ()
314-302

  • Surgical instrument handle, non-torque-limiting
T-Handle, AO and 10mm Socket
Paragon 28, Inc.
P47-940-0001
In Commercial Distribution

  • 00889795145956 ()
P47-940-0001

  • Surgical instrument handle, non-torque-limiting
5mm Trocar
Paragon 28, Inc.
P47-930-0001
In Commercial Distribution

  • 00889795145949 ()
P47-930-0001

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Fixation Pin Drill Sleeve
Paragon 28, Inc.
P47-920-0001
In Commercial Distribution

  • 00889795145932 ()
P47-920-0001

  • Orthopaedic implantation sleeve, reusable
Fixation Pin Drill Sleeve w/ Handle
Paragon 28, Inc.
P47-910-0001
In Commercial Distribution

  • 00889795145925 ()
P47-910-0001

  • Orthopaedic implantation sleeve, reusable
Step Drill, 4.0 x 200mm
Paragon 28, Inc.
P47-100-4020
In Commercial Distribution

  • 00889795145918 ()
P47-100-4020

  • Fluted surgical drill bit, reusable
Step Drill, 3.2 x 165mm
Paragon 28, Inc.
P47-100-3216
In Commercial Distribution

  • 00889795145901 ()
P47-100-3216

  • Fluted surgical drill bit, reusable
Step Drill, 2.4 x 140mm
Paragon 28, Inc.
P47-100-2414
In Commercial Distribution

  • 00889795145895 ()
P47-100-2414

  • Fluted surgical drill bit, reusable
30 Degree Post
Paragon 28, Inc.
P47-510-P030
In Commercial Distribution

  • 00889795145888 ()
P47-510-P030

  • External orthopaedic fixation system, single-use
Straight Post
Paragon 28, Inc.
P47-510-P000
In Commercial Distribution

  • 00889795145871 ()
P47-510-P000

  • External orthopaedic fixation system, single-use
Ankle Fracture 360, 2.7/3.5 mm Screw Caddy, Base
Paragon 28, Inc.
P50-900-2735-1
In Commercial Distribution

  • 00889795145864 ()
P50-900-2735-1

  • Device sterilization/disinfection container, reusable
Carbon Bar, 11mm x 500mm
Paragon 28, Inc.
P47-410-0500
In Commercial Distribution

  • 00889795145840 ()
P47-410-0500

  • External orthopaedic fixation system, single-use
Carbon Bar, 11mm x 450mm
Paragon 28, Inc.
P47-410-0450
In Commercial Distribution

  • 00889795145833 ()
P47-410-0450

  • External orthopaedic fixation system, single-use
Carbon Bar, 11mm x 400mm
Paragon 28, Inc.
P47-410-0400
In Commercial Distribution

  • 00889795145826 ()
P47-410-0400

  • External orthopaedic fixation system, single-use
Carbon Bar, 11mm x 350mm
Paragon 28, Inc.
P47-410-0350
In Commercial Distribution

  • 00889795145819 ()
P47-410-0350

  • External orthopaedic fixation system, single-use
Carbon Bar, 11mm x 300mm
Paragon 28, Inc.
P47-410-0300
In Commercial Distribution

  • 00889795145802 ()
P47-410-0300

  • External orthopaedic fixation system, single-use
Carbon Bar, 11mm x 250mm
Paragon 28, Inc.
P47-410-0250
In Commercial Distribution

  • 00889795145796 ()
P47-410-0250

  • External orthopaedic fixation system, single-use
Carbon Bar, 11mm x 200mm
Paragon 28, Inc.
P47-410-0200
In Commercial Distribution

  • 00889795145789 ()
P47-410-0200

  • External orthopaedic fixation system, single-use
Carbon Bar, 11mm x 150mm
Paragon 28, Inc.
P47-410-0150
In Commercial Distribution

  • 00889795145772 ()
P47-410-0150

  • External orthopaedic fixation system, single-use
8-Pin Multi Pin Clamp
Paragon 28, Inc.
P47-320-0008
In Commercial Distribution

  • 00889795145765 ()
P47-320-0008

  • External orthopaedic fixation system, single-use
5-Pin Multi Pin Clamp
Paragon 28, Inc.
P47-320-0005
In Commercial Distribution

  • 00889795145758 ()
P47-320-0005

  • External orthopaedic fixation system, single-use
Transfixation Pin, 5 x 325mm, Centrally Threaded
Paragon 28, Inc.
P47-220-5325
In Commercial Distribution

  • 00889795145734 ()
P47-220-5325

  • External orthopaedic fixation system, single-use
Half Pin, 5 x 65mm, Blunt-Tipped
Paragon 28, Inc.
P47-210-565B
In Commercial Distribution

  • 00889795145727 ()
P47-210-565B

  • External orthopaedic fixation system, single-use
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