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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EXC ACO 022 U 6-6/ EXM L 7-7 HK 345
Gc Orthodontics America Inc.
11/20-2AA5-9780
In Commercial Distribution

  • D78811202AA597801 ()
11/20-2AA5-9780

  • Orthodontic bracket, metal
  • Orthodontic bracket, ceramic
EXPC CCO U5-5 EXPM MBT L5-5 022 hks345
Gc Orthodontics America Inc.
11/20-2AA5-9752
In Commercial Distribution

  • D78811202AA597521 ()
11/20-2AA5-9752

  • Orthodontic bracket, ceramic
EXPC/M ROTH 022 UL 7-7 HK 3,4,5
Gc Orthodontics America Inc.
11/20-2AA5-9380
In Commercial Distribution

  • D78811202AA593801 ()
11/20-2AA5-9380

  • Orthodontic bracket, ceramic
  • Orthodontic bracket, metal
EXC U 3-3/ EXP M U45, L 5-5 HK 345
Gc Orthodontics America Inc.
11/20-2AA5-8366
In Commercial Distribution

  • D78811202AA583661 ()
11/20-2AA5-8366

  • Orthodontic bracket, metal
  • Orthodontic bracket, ceramic
EXPC/M MBT 022 U/L 7-7 HK 3,4,5
Gc Orthodontics America Inc.
11/20-2AA5-7958
In Commercial Distribution

  • D78811202AA579581 ()
11/20-2AA5-7958

  • Orthodontic bracket, ceramic
EXC U3-3, EXM 4-7, 7-7 CCO 022 HKS 3,4,5
Gc Orthodontics America Inc.
11/20-2AA5-2561
In Commercial Distribution

  • D78811202AA525611 ()
11/20-2AA5-2561

  • Orthodontic bracket, ceramic
EXP C ACO, L 4/5M 022 UL 7-7 FEM 3,4,5HK
Gc Orthodontics America Inc.
11/20-2AA5-0168
In Commercial Distribution

  • D78811202AA501681 ()
11/20-2AA5-0168

  • Orthodontic bracket, ceramic
  • Orthodontic bracket, metal
EXP C U/L 5-5 L 3-3 EXP M L 4,5 HK 345
Gc Orthodontics America Inc.
11/20-1CC5-1120
In Commercial Distribution

  • D78811201CC511201 ()
11/20-1CC5-1120

  • Orthodontic bracket, ceramic
EXP C U4-4 LME U5-L5-5 022 hks 345
Gc Orthodontics America Inc.
11/32-2CC5-6338
In Commercial Distribution

  • D78811322CC563381 ()
11/32-2CC5-6338

  • Orthodontic bracket, ceramic
  • Orthodontic bracket, metal
The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
11" Camouflage
In Commercial Distribution

  • 00812594012457 ()
  • 10812594012454 ()
N9111CO

  • Tracheostomy tube neck holder, single-use
The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
11" Blue
In Commercial Distribution

  • 00812594012389 ()
  • 10812594012386 ()
N9111BL

  • Tracheostomy tube neck holder, single-use
The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
11" Tan
In Commercial Distribution

  • 00812594012310 ()
  • 10812594012317 ()
N9111TN

  • Tracheostomy tube neck holder, single-use
The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
11" Pink
In Commercial Distribution

  • 00812594012242 ()
  • 10812594012249 ()
N9111PK

  • Tracheostomy tube neck holder, single-use
No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE 11
In Commercial Distribution

  • 08800013523006 ()


  • General-purpose ultrasound imaging system
TiAl6V4 ELI sterile
Merete GmbH
2 11
In Commercial Distribution

  • 04048266150011 ()

  • Length: 11 Millimeter
  • Outer Diameter: 2.0 Millimeter
CB30011S

  • Orthopaedic bone screw (non-sliding)
COCR HUMERAL STEM CEMENTED SIZE 6/115MM-STERILE
SYNTHES (U.S.A.) LP
5624-6/11
Not in Commercial Distribution

  • H67956246110 ()
  • 10886982241603 ()
5624611

  • Uncoated shoulder humeral stem prosthesis
TI HUMERAL STEM HA COATED PRESS-FIT SIZE 6/115MM-STERILE
SYNTHES (U.S.A.) LP
5540-6/11
Not in Commercial Distribution

  • H67955406110 ()
  • 10886982241450 ()
5540611

  • Coated shoulder humeral stem prosthesis
TI HUMERAL STEM PRESS-FIT SIZE 6/115MM-STERILE
SYNTHES (U.S.A.) LP
5537-6/11
Not in Commercial Distribution

  • H67955376110 ()
  • 10886982241399 ()
5537611

  • Press-fit shoulder humeral stem prosthesis
No Description
Merete GmbH
2.0 11
In Commercial Distribution

  • 04048266038241 ()

  • Length: 11 Millimeter
CB30011

  • Orthopaedic bone screw (non-sliding)
Orthopaedic implant inserter/extractor, reusable - Gemini SL Total Knee System
WALDEMAR LINK GmbH & Co. KG
317-802/11
In Commercial Distribution

  • 04026575382668 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Tibial Sizer
WALDEMAR LINK GmbH & Co. KG
317-729/11
In Commercial Distribution

  • 04026575366187 ()
317-729/11

  • Knee tibia prosthesis trial, reusable
Femoral Segment,Size 2, lateral and medial
WALDEMAR LINK GmbH & Co. KG
15-2972/11
In Commercial Distribution

  • 04026575340484 ()
15-2972/11

  • Knee arthroplasty wedge
Femoral Segment,Size 1, lateral and medial
WALDEMAR LINK GmbH & Co. KG
15-2971/11
In Commercial Distribution

  • 04026575340248 ()
15-2971/11

  • Knee arthroplasty wedge
Rotational Knee Joint Prosthesis,with anti-luxation device, condylus replacement
WALDEMAR LINK GmbH & Co. KG
15-8521/11
In Commercial Distribution

  • 04026575383245 ()
15-8521/11

  • Rotating hinged total knee prosthesis
Femoral Segment, lateral, cemented
WALDEMAR LINK GmbH & Co. KG
15-8520/11
In Commercial Distribution

  • 04026575372386 ()

  • Height= 25mm
15-8520/11

  • Knee arthroplasty wedge
Femoral Segment, lateral, cemented
WALDEMAR LINK GmbH & Co. KG
15-8519/11
In Commercial Distribution

  • 04026575372324 ()

  • Height= 25mm
15-8519/11

  • Knee arthroplasty wedge
Femoral Segment, lateral, cementless
WALDEMAR LINK GmbH & Co. KG
15-8518/11
In Commercial Distribution

  • 04026575372263 ()

  • Height= 25mm
15-8518/11

  • Knee arthroplasty wedge
Femoral Segment, lateral, cementless
WALDEMAR LINK GmbH & Co. KG
15-8517/11
In Commercial Distribution

  • 04026575372201 ()

  • Height= 25mm
15-8517/11

  • Knee arthroplasty wedge
Hand-held surgical retractor, reusable - LINK SLED Prosthesis
WALDEMAR LINK GmbH & Co. KG
15-2201/11
In Commercial Distribution

  • 04026575341221 ()


  • Hand-held surgical retractor, reusable
Proximal Tibial Spacer,half, incl. flat head screw HEX 2.5 mm
WALDEMAR LINK GmbH & Co. KG
15-2990/11
In Commercial Distribution

  • 04026575419210 ()
15-2990/11

  • Knee arthroplasty wedge
Femoral head prosthesis trial - C.F.P. - Hip Stem
WALDEMAR LINK GmbH & Co. KG
131-940/11
In Commercial Distribution

  • 04026575418671 ()


  • Femoral head prosthesis trial
Bone-resection orthopaedic reamer, reusable - General Instrument
WALDEMAR LINK GmbH & Co. KG
130-370/11
In Commercial Distribution

  • 04026575414796 ()


  • Bone-resection orthopaedic reamer, reusable
Orthopaedic prosthesis instrument, reusable - General Instrument
WALDEMAR LINK GmbH & Co. KG
131-936/11
In Commercial Distribution

  • 04026575414505 ()


  • Femoral head prosthesis trial
Orthopaedic prosthesis instrument, reusable - General Instrument
WALDEMAR LINK GmbH & Co. KG
131-932/11
In Commercial Distribution

  • 04026575414468 ()


  • Femoral head prosthesis trial
Orthopaedic prosthesis instrument, reusable - General Instrument
WALDEMAR LINK GmbH & Co. KG
131-928/11
In Commercial Distribution

  • 04026575414420 ()


  • Femoral head prosthesis trial
Base components with inside anti-rotation pin, incl. 4 setscrews
WALDEMAR LINK GmbH & Co. KG
99-8007/11
In Commercial Distribution

  • 04026575401468 ()

  • Length=110mm
99-8007/11

  • Uncoated hip femur prosthesis, modular
Modular Stem,Cylindrical
WALDEMAR LINK GmbH & Co. KG
15-2951/11
In Commercial Distribution

  • 04026575325894 ()
15-2951/11

  • Knee femur stem prosthesis
Hinge Knee Joint Prosthesis,with anti-luxation device
WALDEMAR LINK GmbH & Co. KG
15-2838/11
In Commercial Distribution

  • 04026575316618 ()
15-2838/11

  • Rotating hinged total knee prosthesis
Hinge Knee Joint Prosthesis,with anti-luxation device
WALDEMAR LINK GmbH & Co. KG
15-2837/11
In Commercial Distribution

  • 04026575316595 ()
15-2837/11

  • Rotating hinged total knee prosthesis
Hinge Knee Joint Prosthesis,with anti-luxation device
WALDEMAR LINK GmbH & Co. KG
15-2836/11
In Commercial Distribution

  • 04026575316571 ()
15-2836/11

  • Rotating hinged total knee prosthesis
Orthopaedic implant inserter/extractor, reusable - LINK Embrace Shoulder System
WALDEMAR LINK GmbH & Co. KG
645-090/11
In Commercial Distribution

  • 04026575314959 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Hinge Knee Joint Prosthesis,with hinge axis
WALDEMAR LINK GmbH & Co. KG
15-2459/11
In Commercial Distribution

  • 04026575321490 ()
15-2459/11

  • Rotating hinged total knee prosthesis
Medullary canal orthopaedic reamer, rigid - LinkSymphoKnee System
WALDEMAR LINK GmbH & Co. KG
881-069/11
In Commercial Distribution

  • 04026575316724 ()


  • Medullary canal orthopaedic reamer, rigid
Hinge Knee Joint Prosthesis,Femoral component
WALDEMAR LINK GmbH & Co. KG
15-2833/11
In Commercial Distribution

  • 04026575316700 ()
15-2833/11

  • Uncoated knee femur prosthesis, metallic
Hinge Knee Joint Prosthesis,Femoral component
WALDEMAR LINK GmbH & Co. KG
15-2832/11
In Commercial Distribution

  • 04026575316687 ()
15-2832/11

  • Uncoated knee femur prosthesis, metallic
Hinge Knee Joint Prosthesis,Femoral component
WALDEMAR LINK GmbH & Co. KG
15-2831/11
In Commercial Distribution

  • 04026575316663 ()
15-2831/11

  • Uncoated knee femur prosthesis, metallic
Hinge Knee Joint Prosthesis,Femoral component
WALDEMAR LINK GmbH & Co. KG
15-2830/11
In Commercial Distribution

  • 04026575316649 ()
15-2830/11

  • Uncoated knee femur prosthesis, metallic
Hinge Knee Joint Prosthesis,with anti-luxation device
WALDEMAR LINK GmbH & Co. KG
15-2835/11
In Commercial Distribution

  • 04026575316557 ()
15-2835/11

  • Rotating hinged total knee prosthesis
Rotational Knee Joint Prosthesis,Femoral component
WALDEMAR LINK GmbH & Co. KG
15-2813/11
In Commercial Distribution

  • 04026575316212 ()
15-2813/11

  • Uncoated knee femur prosthesis, metallic
Rotational Knee Joint Prosthesis,Femoral component
WALDEMAR LINK GmbH & Co. KG
15-2812/11
In Commercial Distribution

  • 04026575316199 ()
15-2812/11

  • Uncoated knee femur prosthesis, metallic
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