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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Szr - Chin Sty 1 Sz 1 NS
Aart
A
In Commercial Distribution

  • B4904001012A0 ()
400-101-2A

  • Chin prosthesis
Silicone Sheeting, 6"x6"x.040 R Sterile
Aart
A
In Commercial Distribution

  • B4902016640A0 ()
201-66-40A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 6"x6"x.040 R NS
Aart
A
In Commercial Distribution

  • B49020166408A0 ()
201-66-40-8A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 6"x6"x.030 R Sterile
Aart
A
In Commercial Distribution

  • B4902016630A0 ()
201-66-30A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 6"x6"x.030 R NS
Aart
A
In Commercial Distribution

  • B49020166308A0 ()
201-66-30-8A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 6"x6"x.020 R Sterile
Aart
A
In Commercial Distribution

  • B4902016620A0 ()
201-66-20A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 6"x6"x.020 R NS
Aart
A
In Commercial Distribution

  • B49020166208A0 ()
201-66-20-8A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 6"x6"x.010 R Sterile
Aart
A
In Commercial Distribution

  • B4902016610A0 ()
201-66-10A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 6"x6"x.010 R NS
Aart
A
In Commercial Distribution

  • B49020166108A0 ()
201-66-10-8A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 3"x3"x.030 R Sterile
Aart
A
In Commercial Distribution

  • B4902013330A1 ()
  • B4902013330A0 ()
201-33-30A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 3"x3"x.020 R Sterile
Aart
A
In Commercial Distribution

  • B4902013320A1 ()
  • B4902013320A0 ()
201-33-20A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 3"x3"x.010 R Sterile
Aart
A
In Commercial Distribution

  • B4902013310A1 ()
  • B4902013310A0 ()
201-33-10A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 6"x6"x.040 NR Sterile
Aart
A
In Commercial Distribution

  • B4902006640A0 ()
200-66-40A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 6"x6"x.040 NR NS
Aart
A
In Commercial Distribution

  • B49020066408A0 ()
200-66-40-8A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 6"x6"x.030 NR Sterile
Aart
A
In Commercial Distribution

  • B4902006630A0 ()
200-66-30A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 6"x6"x.030 NR NS
Aart
A
In Commercial Distribution

  • B49020066308A0 ()
200-66-30-8A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 6"x6"x.020 NR Sterile
Aart
A
In Commercial Distribution

  • B4902006620A0 ()
200-66-20A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 6"x6"x.020 NR NS
Aart
A
In Commercial Distribution

  • B49020066208A0 ()
200-66-20-8A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 6"x6"x.010 NR Sterile
Aart
A
In Commercial Distribution

  • B4902006610A0 ()
200-66-10A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 6"x6"x.010 NR NS
Aart
A
In Commercial Distribution

  • B49020066108A0 ()
200-66-10-8A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 6"x6"x.005 NR Sterile
Aart
A
In Commercial Distribution

  • B4902006605A0 ()
200-66-05A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 6"x6"x.005 NR NS
Aart
A
In Commercial Distribution

  • B49020066058A0 ()
200-66-05-8A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 3"x3"x.040 NR Sterile
Aart
A
In Commercial Distribution

  • B4902003340A1 ()
  • B4902003340A0 ()
200-33-40A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting, 3"x3"x.030 NR Sterile
Aart
A
In Commercial Distribution

  • B4902003330A1 ()
  • B4902003330A0 ()
200-33-30A

  • Silicone-sheet tissue reconstructive material
Silicone Sheeting,12"x12"x.005 NR Sterile
Aart
A
In Commercial Distribution

  • B4902001205A0 ()
200-12-05A

  • Silicone-sheet tissue reconstructive material
The SmartBone is a 3D-printed, patient-specific device that is used to set the Glenoid Intelligent Reusable Instrument (IRI) at the time of surgery. This bone model is a 1-to-1 representation of a specific patient's bony anatomy. The SmartBone is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
A
Not in Commercial Distribution

  • 00811813020235 ()

  • Patient-specific
0006-0007-UPI

  • Orthopaedic prosthesis implantation positioning instrument, single-use
ShangRing Male Circumcision Device Self-locking
Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd.
A
In Commercial Distribution

  • 26939550822368 ()
  • 16939550822361 ()
  • 86939550822360 ()


  • Surgical penis clamp, single-use
Adult SpO2 Sensor Two Piece
Covidien LP
A
In Commercial Distribution

  • 10884522042123 ()
  • 20884522042120 ()

  • Patient Weight, >30, KG;


  • Transcutaneous blood gas monitor sensor
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
XACT ACE Xtend Remote
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 07290017702377 ()
PR06ASA057003

  • Computer/medical device keyboard
2.1 mm Ablation Instrument Insertion Kit
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 17290017702336 ()
  • 07290017702339 ()
XR-2.1MM-ABL-IIK

  • Robotic surgical needle holder, single-use
1.7 mm Ablation Instrument Insertion Kit
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 17290017702312 ()
  • 07290017702315 ()
XR-1.7MM-ABL-IIK

  • Robotic surgical needle holder, single-use
1.5mm Ablation Instrument Insertion Kit
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 07290017702308 ()
  • 17290017702305 ()
XR-1.5MM-ABL-IIK

  • Robotic surgical needle holder, single-use
Frame-Harness Strap Set
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 07290017702278 ()
XR-FRM-HRN

  • Medical/surgical interventional tube/cable securement strap
Respiration Sensor Harness Strap
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 17290017702268 ()
  • 07290017702261 ()
XR-RS-HRN

  • Medical/surgical interventional tube/cable securement strap
Respiration Sensor All Around Strap
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 17290017702220 ()
  • 07290017702223 ()
XR-RS-AAS

  • Electronic goniometer/kinesiology sensor
Small Harness
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 17290017702213 ()
  • 07290017702216 ()
XR-SM-HRN

  • Radiological general body-part positioner
Medium Harness
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 07290017702209 ()
XR-MD-HRN

  • Radiological general body-part positioner
Extra-Large Harness
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 17290017702190 ()
  • 07290017702193 ()
XR-XL-HRN

  • Radiological general body-part positioner
Large Harness
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 07290017702186 ()
  • 17290017702183 ()
XR-LG-HRN

  • Radiological general body-part positioner
XACT Robotics: Disposable Kit
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 17290017702152 ()
  • 07290017702155 ()
XR-DIS-KIT

  • Medical equipment/instrument drape, single-use
  • Robotic surgical needle holder, single-use
  • Radiological general body-part positioner
  • Medical/surgical interventional tube/cable securement strap
Respiration Sensor Drape
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 07290017702100 ()
XR-RS-DRP

  • Medical equipment/instrument drape, single-use
Robot Medical Drape
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 17290017702091 ()
  • 07290017702094 ()
XR-RBT-DRP

  • Medical equipment/instrument drape, single-use
19G Instrument Insertion Kit
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 17290017702060 ()
  • 07290017702063 ()
XR-19G-IIK

  • Robotic surgical needle holder, single-use
18G Instrument Insertion Kit
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 17290017702053 ()
  • 07290017702056 ()
XR-18G-IIK

  • Robotic surgical needle holder, single-use
17G Instrument Insertion Kit
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 17290017702046 ()
  • 07290017702049 ()
XR-17G-IIK

  • Robotic surgical needle holder, single-use
A device used to mix the powder and liquid in application capsules intended for use in dental treatments.
E.M.S. Electro Medical Systems (Hangzhou)Co.,Ltd.
A
In Commercial Distribution

  • 06971503860788 ()
Y200F6D490 9050

  • Dental amalgam mixer
Mobile x-ray device
Solutions For Tomorrow AB
A
In Commercial Distribution

  • 07350011170012 ()


  • Mobile basic diagnostic x-ray system, digital
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450619763 ()
  • 00884450619766 ()

  • French Size (F)-6F
  • Recommended Guide Wire-0.038" (0.97 mm)
  • Length-125 cm
  • Label Long Description-MIV RAD PIG LT
6RPL125

  • Angiographic catheter, single-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450619459 ()
  • 00884450619452 ()

  • French Size (F)-5F
  • Length-135 cm
  • Label Long Description-BERENSTEIN 1
  • Recommended Guide Wire-0.038" (0.97 mm)
PV513538BERN

  • Angiographic catheter, single-use
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