SEARCH RESULTS FOR: 2023(1599 results)

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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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momcozy - 06975740360209

The Wearable Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device is intended for a single user.
Shenzhen Lutejiacheng Technology Co., Ltd.
S9 Pro-grey
In Commercial Distribution

  • 06975740369011 ()
  • 06975740360209 ()
  • 06975740369028 ()


  • Breast pump, electric

momcozy - 06975740360193

The Wearable Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device is intended for a single user.
Shenzhen Lutejiacheng Technology Co., Ltd.
S9 Pro-grey-D
In Commercial Distribution

  • 06975740369035 ()
  • 06975740360193 ()
  • 06975740369042 ()
  • 06975740360407 ()


  • Breast pump, electric

momcozy - 06975740360186

The Wearable Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device is intended for a single user.
Shenzhen Lutejiacheng Technology Co., Ltd.
S12 Pro-white
In Commercial Distribution

  • 06975740369059 ()
  • 06975740360186 ()
  • 06975740369066 ()


  • Breast pump, electric

HEALIFY - 06971712724598

No Description
Hong Qiangxing (Shen Zhen) Electronics Limited
TENS
In Commercial Distribution

  • 06971712724581 ()
  • 06971712724598 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

InterStim™ SureScan™ - 00763000596958

LEAD 978B133 ISTM SSMRI 4.32MM EMAN GLBL
MEDTRONIC, INC.
978B133
In Commercial Distribution

  • 00763000596958 ()

  • Length: 33.0 Centimeter


  • Sacral plexus implantable incontinence-control electrical stimulation system electrode

Abena - 00810049810191

4-ply mask
Abena North America, Inc
1000020586
Not in Commercial Distribution

  • 00810049810207 ()
  • 00810049810191 ()


  • Public face mask, single-use

YO Home Sperm Test - 07290016650587

No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
YO Universal 2.0 packed kit for BirdandBe - 2 tests
In Commercial Distribution

  • 07290016650587 ()
YO-FA-01912-00

  • Motile sperm concentration IVD, kit, imaging, self-testing

LAMEVEN Eye Massager - 06975977230016

No Description
Dongguan City Umed Technology Co., Ltd
MD-206
Not in Commercial Distribution

  • 16975977230013 ()
  • 06975977230016 ()


  • Eyelid massager

Fiducial Coil with Arm Mount (Receive Only) - 00850042098042

The Promaxo Fiducial Coil with Arm Mount is a 1-channel, receive-only coil to be used in conjunction with the Promaxo MRI System (PR071-001-M, PR071-001-R).
Promaxo, Inc.
7181
Not in Commercial Distribution

  • 00850042098042 ()
7181

  • MRI system coil, radio-frequency

MRI Medium Receive Coil - 00850042098035

The Promaxo Medium Receive Coil Model 6761-M is a 5-channel, receive-only phased array coil to be used in conjunction with the Promaxo MRI System (PR071-001-M, PR071-001-R).
Promaxo, Inc.
6761-M
Not in Commercial Distribution

  • 00850042098035 ()
6761-M

  • MRI system coil, radio-frequency

MRI Large Receive Coil - 00850042098028

The Promaxo Large Receive Coil Model 6761-L is a 5-channel, receive-only phased array coil to be used in conjunction with the Promaxo MRI System (PR071-001-M, PR071-001-R).
Promaxo, Inc.
6761-L
Not in Commercial Distribution

  • 00850042098028 ()
6761-L

  • MRI system coil, radio-frequency

Nexxis - 05415334001626

MNA-240 DEC V2 AT
Barco NV
MNA-240
Not in Commercial Distribution

  • 05415334001626 ()
K9303271A

  • Operating room audiovisual data/device management system

SMOOTHSKIN - 05060352783964

Light Based Over-The-Counter Hair Removal
CYDEN LIMITED
SmoothSkin Bare+
Not in Commercial Distribution

  • 05060352784145 ()
  • 05060352783964 ()


  • Home-use intense pulsed light hair removal unit

SMOOTHSKIN - 05060352782608

Light based Over-The-Counter Hair Removal
CYDEN LIMITED
SmoothSkin Pure
Not in Commercial Distribution

  • 05060352782837 ()
  • 05060352782608 ()


  • Home-use intense pulsed light hair removal unit

EndoRotor® XT Catheter 3.2mm x 1890mm - 00854172008063

No Description
INTERSCOPE, INC
ER 10-01-OP-S
Not in Commercial Distribution

  • 00854172008063 ()
ER 10-01-OP-S

  • Tissue morcellation system handpiece, line-powered

EndoRotor® XT Catheter 3.2mm x 1270mm - 00854172008056

No Description
INTERSCOPE, INC
ER 10-03-F-S
Not in Commercial Distribution

  • 00854172008056 ()
ER 10-03-F-S

  • Tissue morcellation system handpiece, line-powered

EndoRotor® Catheter 3.2mm x 1240mm - 00854172008032

No Description
INTERSCOPE, INC
ER 10-03-OP
Not in Commercial Distribution

  • 00854172008032 ()
ER 10-03-OP

  • Tissue morcellation system handpiece, line-powered

EndoRotor® Catheter 3.2mm x 1540mm - 00854172008018

No Description
INTERSCOPE, INC
ER 10-02-O
Not in Commercial Distribution

  • 00854172008018 ()
ER 10-02-O

  • Tissue morcellation system handpiece, line-powered

EndoRotor® Catheter 3.2mm x 1890mm - 00854172008001

No Description
INTERSCOPE, INC
ER 10-01-OP
Not in Commercial Distribution

  • 00854172008001 ()
ER 10-01-OP

  • Tissue morcellation system handpiece, line-powered

De Soutter Medical - 05051471032316

SAW HANGER BRACKET - CC5/6
DE SOUTTER MEDICAL LIMITED
7670
Not in Commercial Distribution

  • 05051471032316 ()
7670

  • Medical device storage mount

De Soutter Medical - 05051471089846

HST BUR
DE SOUTTER MEDICAL LIMITED
H51-0520
Not in Commercial Distribution

  • 15051471089843 ()
  • 05051471089846 ()
H51-0520

  • Orthopaedic bur, single-use

De Soutter Medical - 05051471089761

HST BUR
DE SOUTTER MEDICAL LIMITED
H50-0520
Not in Commercial Distribution

  • 15051471089768 ()
  • 05051471089761 ()
H50-0520

  • Orthopaedic bur, single-use

De Soutter Medical - 05051471025295

SAGITTAL BLADE - MICROAIRE (1200-009) 10.2 x 18 x 0.50mm
DE SOUTTER MEDICAL LIMITED
S72-009
Not in Commercial Distribution

  • 15051471025292 ()
  • 05051471025295 ()
S72-009

  • Surgical saw blade, sagittal, single-use

De Soutter Medical - 05051471025257

SAGITTAL BLADE - MICROAIRE (1200-007) 4.3 x 15 x 0.50mm
DE SOUTTER MEDICAL LIMITED
S72-007
Not in Commercial Distribution

  • 15051471025254 ()
  • 05051471025257 ()
S72-007

  • Surgical saw blade, sagittal, single-use

De Soutter Medical - 05051471021631

CAST CUTTER BLADE 63.5mm DIA ZIMMER HUB
DE SOUTTER MEDICAL LIMITED
77262
Not in Commercial Distribution

  • 05051471021631 ()
77262

  • Cast cutter blade

De Soutter Medical - 05051471005747

SAGITTAL BLADE - MICROAIRE (1200-005) 6.9 x 20 x 0.50mm
DE SOUTTER MEDICAL LIMITED
S72-005
Not in Commercial Distribution

  • 15051471005744 ()
  • 05051471005747 ()
S72-005

  • Surgical saw blade, sagittal, single-use

De Soutter Medical - 05051471005198

VAC POWER SUPPLY MOUNTING KIT
DE SOUTTER MEDICAL LIMITED
6310
Not in Commercial Distribution

  • 05051471005198 ()
6310

  • Medical device storage mount

Abena - 05713571001585

Abena Slip Flexi Fit L-XL4, Premium holds 128 fluid ounces/3800 ml, for individuals with hip and waist measurements of 43-67".
Abena North America, Inc
1000021167
In Commercial Distribution

  • 57135710001592 ()
  • 05713571001585 ()


  • Adult nappy

Abena - 05713571001561

Abena Slip Flexi Fit M-L4, Premium holds 115 fluid ounces/3400ml, for individuals with hip and waist measurements from 28-47"
Abena North America, Inc
1000021166
In Commercial Distribution

  • 05713571001578 ()
  • 05713571001561 ()


  • Adult nappy

Abena - 05713571001028

Abena Pants XL3, Premium holds 88 fluid ounces/2600 ml, for individuals for waist and hip measurements of 51-67". Generally it is classified as a XL size.
Abena North America, Inc
1000021330
In Commercial Distribution

  • 05713571001035 ()
  • 05713571001028 ()


  • Adult nappy
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