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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No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08419009
In Commercial Distribution

  • 04056869001272 ()
8419009..

  • Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10910501
In Commercial Distribution

  • 04056869001265 ()


  • Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10910500
In Commercial Distribution

  • 04056869001258 ()


  • Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08717741
In Commercial Distribution

  • 04056869001166 ()


  • Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10275879
In Commercial Distribution

  • 04056869001159 ()


  • Stationary gamma camera system
830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution

  • 00195278788252 ()
5376204-33

  • Stationary gamma camera system
MyoSPECT ES to MyoSPECT Upgrade kit
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BS
In Commercial Distribution

  • 00195278722546 ()
5941445

  • Stationary gamma camera system
MyoSPECT ES MDR GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BD
In Commercial Distribution

  • 00195278488626 ()
5875815-40

  • Stationary gamma camera system
MyoSPECT MDR GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BC
In Commercial Distribution

  • 00195278488619 ()
5875815-30

  • Stationary gamma camera system
MyoSPECT GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912AA
In Commercial Distribution

  • 00195278421586 ()
5875815-10

  • Stationary gamma camera system
MyoSPECT ES GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912AB
In Commercial Distribution

  • 00195278421579 ()
5875815-20

  • Stationary gamma camera system
Number of legs: Double Leg length: eXtra long Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DXWUS
In Commercial Distribution

  • 04560340091091 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Long Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DLWUS
In Commercial Distribution

  • 04560340091084 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Medium Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DMWUS
In Commercial Distribution

  • 04560340091077 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Short Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DSWUS
In Commercial Distribution

  • 04560340091060 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: eXtra long Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DXMUS
In Commercial Distribution

  • 04560340090971 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Long Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DLMUS
In Commercial Distribution

  • 04560340090964 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Medium Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DMMUS
In Commercial Distribution

  • 04560340090957 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Short Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DSMUS
In Commercial Distribution

  • 04560340090940 ()


  • Neuro-controlled ambulation exoskeleton
Vector Trolley Assembly, Elite Model
BIONESS INC.
VEC-1100
In Commercial Distribution

  • 00815962020276 ()


  • Gait rehabilitation frame, electric
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003034 ()
203511 SD

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003027 ()

  • Length: 30 Millimeter
  • Length: 35 Millimeter
  • Length: 40 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511

  • Intraurethral valve/pump
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003010 ()
403507

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003003 ()
203511 SD

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003002 ()

  • Length: 60 Millimeter
  • Length: 55 Millimeter
  • Length: 50 Millimeter
  • Length: 45 Millimeter
  • Length: 40 Millimeter
  • Length: 35 Millimeter
  • Length: 30 Millimeter
203511

  • Intraurethral valve/pump
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003001 ()
403507

  • Intraurethral valve/pump
Vector Gait and Safety System, Base Model
BIONESS INC.
VEC-3000
In Commercial Distribution

  • 00815962020283 ()


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

  • 00815962020269 ()


  • Gait rehabilitation frame, electric
Models 400 and 550 Implantable Infusion Pump Refill Kit Contents: (1) 50 ml Calibrated Syringe Barrel (1) Tubing Set with Removable Injection Site (1) Stopcock (2) Huber Point Needles 22 Gauge x 1inch (2.54 cm) (2) Huber Point Needles 22 Gauge x 1.5inch (3.8 cm) (6) Gauze Pads (1) Fenestrated Drape (2) Pump Templates (2) Adhesive Bandages (1) Refill Worksheet (1) Set of INSTRUCTIONS FOR USE
Medos International Sàrl
IP40820US
Not in Commercial Distribution

  • 10886704078845 ()
IP40820US

  • Implantable intrathecal infusion pump, nonprogrammable
FOR USE WITH CODMAN 3000 series IMPLANTABLE DRUG DELIVERY SYSTEM Contents: (1) 50 ml Calibrated Syringe Barrel (1) Tubing Set (1) Stopcock (2) Huber Point Needles: 22 Gauge x 1.5" (3.8 cm) (6) Gauze Pads (1) Fenestrated Drape (1) Data Sticker (2) Adhesive Bandages (1) Refill Worksheet (1) INSTRUCTIONS FOR USE (2) Instruction Posters
Medos International Sàrl
AP07014US
Not in Commercial Distribution

  • 10886704078838 ()
AP07014US

  • Implantable intrathecal infusion pump, nonprogrammable
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