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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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Axiom - 00840363306056

4 x 5 Lateral Pads with Fixed Mounting Hardware - Pair
KI MOBILITY, LLC
PB
In Commercial Distribution

  • 00840363306056 ()

  • 4 x 5
PBLF4X5PP

  • Wheelchair bracket/mount

Axiom - 00840363306049

3 x 4 Lateral Pads with Fixed Mounting Hardware - Pair
KI MOBILITY, LLC
PB
In Commercial Distribution

  • 00840363306049 ()

  • 3 x 4
PBLF3x4PP

  • Wheelchair bracket/mount

Axiom - 00840363305820

Comfort Soft Headrest, 14" with Standard Straight Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305820 ()

  • 14"
CS14SS

  • Wheelchair bracket/mount

Axiom - 00840363305813

Comfort Soft Headrest, 10" with Standard Straight Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305813 ()

  • 10"
CS10SS

  • Wheelchair bracket/mount

Axiom - 00840363305806

Comfort Soft Headrest, 8" with Standard Straight Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305806 ()

  • 8"
CS08SS

  • Wheelchair bracket/mount

UMF Medical - 00815235023751

20-1/8 IN. STIRRUP ASSEMBLY W/ ATTACHMENT HARDWARE(replaces R1-3016)
UNITED METAL FABRICATORS, INC.
R1-3534
In Commercial Distribution

  • 00815235023751 ()


  • Heel stirrup

Probasics - 00815067013364

K4 Deluxe 20" Seat Extender w/ Seat Tube and Hardware
COMPASS HEALTH BRANDS CORP.
X1WC4DAM24
In Commercial Distribution

  • 00815067013364 ()


  • Push-rim manual wheelchair, non-bariatric

Probasics - 00815067013340

K4 Deluxe 16" Seat Extender w/ Seat Tube and Hardware
COMPASS HEALTH BRANDS CORP.
X1WC4DAM22
In Commercial Distribution

  • 00815067013340 ()


  • Push-rim manual wheelchair, non-bariatric

Probasics - 00815067013357

K4 Deluxe 18" Seat Extender w/ Seat Tube and Hardware
COMPASS HEALTH BRANDS CORP.
X1WC4DAM23
In Commercial Distribution

  • 00815067013357 ()


  • Push-rim manual wheelchair, non-bariatric

Probasics - 00815067013166

K4 Deluxe 22" Seat Extender w/ Seat Tube and Hardware
COMPASS HEALTH BRANDS CORP.
X1WC4DAM25
In Commercial Distribution

  • 00815067013166 ()


  • Push-rim manual wheelchair, non-bariatric

LOGIQ - 00195278835758

LOGIQ Fortis R3 to R4 Upgrade with Hardware including Wireless
GE Ultrasound Korea Ltd.
Fortis R3 to R4 HW Upgrade W
In Commercial Distribution

  • 00195278835758 ()
5946728

  • General-purpose ultrasound imaging system

Straumann SIRIOS X3 - 06973993442840

Straumann SIRIOS™ X3 Intraoral scanner Hardware As A Service
Alliedstar Medical Equipment Co., Ltd.
ST 300E
In Commercial Distribution

  • 06973993442840 ()
STS-6583448-H

  • Intraoral optical scanning system

PowerLook PRO+ Hardware Platform GE - 00850008977114

No Description
Icad, Inc.
DSC018-02
In Commercial Distribution

  • 00850008977114 ()


  • Radiology DICOM image processing application software

Powerlook PRO Hardware Upgrade, SLD - 00858012005823

The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005823 ()
DSC017-03-ROW

  • Basic diagnostic x-ray system application software

Powerlook PRO Hardware Upgrade, SLD - 00858012005809

The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005809 ()
DSC017-02-ROW

  • Basic diagnostic x-ray system application software

Powerlook PRO Hardware Upgrade, SLD - 00858012005793

The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005793 ()
DSC017-02-US

  • Basic diagnostic x-ray system application software

E2 Carbon Fiber Fixed Hardware - 07540147001339

E2 Carbon Fiber Fixed Mounting Hardware (set). Fixed mounting hardware option for Matrx E2 Carbon Fiber Backs (16H or less). Requires tools to remove. (Fits 3/4", 7/8" or 1" back cane diameters)
Motion Concepts Inc
CFFX
In Commercial Distribution

  • 07540147001339 ()
CFFX

  • Wheelchair back rest positioner

E2 Extended Range Mounting Hardware - 07540147001254

E2 Extended Range Mounting Hardware (pair); includes E2 EasySet Mounting Pin Interface Brackets. Optional hardware for Matrx E2 Backs (18H/20H). Allows for an additional 2" of depth adjustment.
Motion Concepts Inc
E2ERMH
In Commercial Distribution

  • 07540147001254 ()
E2ERMH

  • Wheelchair back rest positioner

E2 EasySet Removable Mounting Hardware - 07540147001193

E2 EasySet Removable Mounting Hardware (pair); includes E2 EasySet Mounting Pin Interface Brackets. Optional mounting hardware for Matrx E2 Backs (18H/20H). Quick-release design.
Motion Concepts Inc
E2EMH
In Commercial Distribution

  • 07540147001193 ()
E2EMH

  • Wheelchair back rest positioner

E2 MiniSet Removable Mounting Hardware - 07540147001186

E2 MiniSet Removable Mounting Hardware (pair); includes E2 MiniSet Mounting Pin Interface Brackets. Optional mounting hardware for Matrx E2 Backs (16H or less). Quick-release design.
Motion Concepts Inc
E2MMH
In Commercial Distribution

  • 07540147001186 ()
E2MMH

  • Wheelchair back rest positioner

Mini Back Hardware Extension Kit - 07540147000608

Mini Back Hardware Extension Kit (pair). For use with MSMH. Extension kit allows offset height adjustment/installation of the Matrx Mini Back (±2.4" or ±3.6")
Motion Concepts Inc
MINI-EXT
In Commercial Distribution

  • 07540147000608 ()
MINI-EXT

  • Wheelchair back rest positioner

MX2 Removable Heavy-Duty Mounting Hardware - 07540147000295

MX2 Removable Heavy-Duty Mounting Hardware (pair) for optional use with the Matrx MX2 Back. (Fits 3/4", 7/8" and 1" back canes). Quick-release design.
Motion Concepts Inc
IMX2QRH-HD
In Commercial Distribution

  • 07540147000295 ()
IMX2QRH-HD

  • Wheelchair back rest positioner

MX2 Fixed Heavy-Duty Mounting Hardware - 07540147000271

MX2 Fixed Heavy-Duty Mounting Hardware (pair) for optional use with the Matrx MX2 Back. (Fits 3/4", 7/8" and 1" back canes). Requires tools for removal.
Motion Concepts Inc
IMX2CFH-HD
In Commercial Distribution

  • 07540147000271 ()
IMX2CFH-HD

  • Wheelchair back rest positioner

Extended Range Mounting Hardware Upgrade - 07540147000226

Extended Range Mounting Hardware upgrade (pair). Provides additional 2" depth adjustment for PBMH and HDMH.
Motion Concepts Inc
ERMHU
In Commercial Distribution

  • 07540147000226 ()
ERMHU

  • Wheelchair back rest positioner

Fixed Space Saver Mounting Hardware - 07540147000202

Fixed Space Saver Mounting Hardware (pair). (Fits 3/4", 7/8" and 1" back canes). Requires tools for removal. Permanent mount recommended for Power Wheelchair application or when portability is not required. Recommended for Tilt/Recline applications
Motion Concepts Inc
FSSH
In Commercial Distribution

  • 07540147000202 ()
FSSH

  • Wheelchair back rest positioner

HeRO duet - 00865536000234

A standalone HeRO monitor for two infants
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000234 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware

HeRO solo - 00865536000227

A HeRO System for the private room
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000227 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware

HeRO ES - 00865536000210

No Description
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000210 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware

HeRO symphony - 00865536000203

Server based HeRO System
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000203 ()


  • Neonatal/paediatric heart rate monitoring hardware
  • Neonatal/paediatric heart rate monitoring application software

Prelude - 04260308110108

The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device. It assists to find product specific machine parameters for treatment and can send those proposals to the console of the device. The machine parameters are not intended to be used for direct control for the radiation device.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1. EBRT
In Commercial Distribution

  • 04260308110108 ()


  • Radiation therapy software

Prelude - 04260308110092

The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device. It assists to find product specific machine parameters for treatment and can send those proposals to the console of the device. The machine parameters are not intended to be used for direct control for the radiation device.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1. IORT
In Commercial Distribution



  • Radiation therapy software

Prelude - 04260308110078

The Prelude software supports intra-operative radiation therapy workflows with intra-operative radiation devices like IntraOp Mobetron. It assists to find product specific machine parameters for treatment and can send those proposals to the intra-operative radiation device. The machine parameters are not intended to be used for direct control for the radiation device. Machine Output Quality can be visualized and recorded over time for quality assurance.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1.
In Commercial Distribution

  • 04260308110078 ()


  • Radiation therapy software

LUNA 3D - 04260590372642

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA SGRT PC
In Commercial Distribution

  • 04260590372642 ()
0018346-0003

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372604

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Camera Pod
Not in Commercial Distribution

  • 04260590372604 ()
0018914

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372581

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Distribution Box
In Commercial Distribution

  • 04260590372581 ()
0018364-0008

  • Radiological video camera patient positioning/tracking system

DIERS postura - 04260242060194

No Description
DIERS International GmbH
n/a
In Commercial Distribution

  • 04260242060194 ()


  • Radiological video camera patient positioning/tracking system

DIERS statico - 04260242060101

No Description
DIERS International GmbH
II
In Commercial Distribution

  • 04260242060101 ()


  • Radiological video camera patient positioning/tracking system

DIERS formetric - 04260242060019

No Description
DIERS International GmbH
III 4D
In Commercial Distribution

  • 04260242060019 ()


  • Radiological video camera patient positioning/tracking system

VeriSuite - 04260308110023

No Description
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
1.8
In Commercial Distribution

  • 04260308110023 ()


  • Radiation therapy software

LUNA 3D - 04260590372680

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Camera Pod
In Commercial Distribution

  • 04260590372680 ()
0018365-0001

  • Radiological video camera patient positioning/tracking system
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