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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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RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
5I41NU-162043A
In Commercial Distribution

  • 00840828184359 ()
27112

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
4I416U-301045A
In Commercial Distribution

  • 00840828100045 ()
19682

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
4I412U-101440A
In Commercial Distribution

  • 00840828100038 ()
19804

  • Pillow speaker
RESPONDER 5, ENHANCED
CURBELL MEDICAL PRODUCTS, INC.
4C410U-167031A
In Commercial Distribution

  • 00840828100007 ()
18029

  • Pillow speaker
The product, PointerShell 5 mm is a product variant for the navigation of shavers or surgical instruments without motor in the handle and are referred to as ,PointerShell. The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation System using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where, reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0129011 ()
  • EFIAE0129010 ()


  • Multi-purpose stereotactic surgery system
crea.lign Opaker 5 C2/C3/D2/D4 4 g
bredent GmbH & Co. KG
CLFHOP05
In Commercial Distribution

  • EBRECLFHOP059 ()
  • EBRECLFHOP050 ()
CLFHOP05

  • Dental veneer, professional
No Description
AMI Agency for Medical Innovations GmbH
ESI1530
Not in Commercial Distribution

  • EAMIESI15300 ()

  • Shaft Length: 420 Millimeter
  • Outer Diameter: 5 Millimeter
ESI1530

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
ESI1510
Not in Commercial Distribution

  • EAMIESI15100 ()

  • Outer Diameter: 5 Millimeter
  • Shaft Length: 250 Millimeter
ESI1510

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
ESH1530
Not in Commercial Distribution

  • EAMIESH15300 ()

  • Shaft Length: 420 Millimeter
  • Outer Diameter: 5 Millimeter
ESH1530

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
ESH1520
Not in Commercial Distribution

  • EAMIESH15200 ()

  • Shaft Length: 340 Millimeter
  • Outer Diameter: 5 Millimeter
ESH1520

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
ESH1510
Not in Commercial Distribution

  • EAMIESH15100 ()

  • Shaft Length: 250 Millimeter
  • Outer Diameter: 5 Millimeter
ESH1510

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
EAS1530
Not in Commercial Distribution

  • EAMIEAS15300 ()

  • Shaft Length: 420 Millimeter
  • Outer Diameter: 5 Millimeter
EAS1530

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
EAS1520
Not in Commercial Distribution

  • EAMIEAS15200 ()

  • Shaft Length: 340 Millimeter
  • Outer Diameter: 5 Millimeter
EAS1520

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
EAS1510
Not in Commercial Distribution

  • EAMIEAS15100 ()

  • Shaft Length: 250 Millimeter
  • Outer Diameter: 5 Millimeter
EAS1510

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
ESI1520
Not in Commercial Distribution

  • EAMIESI15200 ()

  • Shaft Length: 340 Millimeter
  • Outer Diameter: 5 Millimeter
ESI1520

  • Electrosurgical handpiece, reusable
No Description
Roche Diagnostics GmbH
06331092190
In Commercial Distribution

  • 04015630946204 ()
06331092190

  • Anti-Mullerian hormone (AMH) IVD, calibrator
No Description
Roche Diagnostics GmbH
05917824160
In Commercial Distribution

  • 04015630927807 ()
05917824160

  • Multiple-type clinical chemistry analyte profile IVD, control
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
4I4113U-C010230
In Commercial Distribution

  • 00840828162197 ()
22780

  • Pillow speaker
RESPONDER 5, ENHANCED
CURBELL MEDICAL PRODUCTS, INC.
4C410U-H65041A
In Commercial Distribution

  • 00840828162166 ()
22777

  • Pillow speaker
RESPONDER 5, ENHANCED
CURBELL MEDICAL PRODUCTS, INC.
4C410U-1690311
In Commercial Distribution

  • 00840828161749 ()
22611

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
4I412U-D63034A
In Commercial Distribution

  • 00840828161220 ()
22520

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
4I41ZU-201400A
In Commercial Distribution

  • 00840828161206 ()
22475

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
4I41XU-101383A
In Commercial Distribution

  • 00840828161183 ()
22505

  • Pillow speaker
RESPONDER 5, ENHANCED
CURBELL MEDICAL PRODUCTS, INC.
4C410U-101001F
In Commercial Distribution

  • 00840828161169 ()
22490

  • Pillow speaker
RESPONDER 5, ENHANCED
CURBELL MEDICAL PRODUCTS, INC.
4C410U-172031A
In Commercial Distribution

  • 00840828161053 ()
22465

  • Pillow speaker
RESPONDER 5, ENHANCED
CURBELL MEDICAL PRODUCTS, INC.
4C410U-101541A
In Commercial Distribution

  • 00840828161046 ()
22464

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
4I41JU-101407A
In Commercial Distribution

  • 00840828160995 ()
22468

  • Pillow speaker
RESPONDER 5, ENHANCED
CURBELL MEDICAL PRODUCTS, INC.
4C410U-101531A
In Commercial Distribution

  • 00840828160728 ()
22368

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
4I416U-30104BA
In Commercial Distribution

  • 00840828160704 ()
22375

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
4I41TU-901411A
In Commercial Distribution

  • 00840828160636 ()
22347

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
4I4113U-C01303F
In Commercial Distribution

  • 00840828160445 ()
22316

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
4I414U-501041A
In Commercial Distribution

  • 00840828160421 ()
22293

  • Pillow speaker
RESPONDER 5,ENHANCED
CURBELL MEDICAL PRODUCTS, INC.
4C410U-H65031A
In Commercial Distribution

  • 00840828160322 ()
22266

  • Pillow speaker
RESPONDER 5, ENHANCED
CURBELL MEDICAL PRODUCTS, INC.
4C410U-F71033A
In Commercial Distribution

  • 00840828159685 ()
22206

  • Pillow speaker
RESPONDER 5,ENHANCED
CURBELL MEDICAL PRODUCTS, INC.
4C410U-D70033A
In Commercial Distribution

  • 00840828159678 ()
22204

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
4I41TU-901341A
In Commercial Distribution

  • 00840828159470 ()
22155

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
4I412U-1010011
In Commercial Distribution

  • 00840828159456 ()
22165

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
4I414U-101033F
In Commercial Distribution

  • 00840828159203 ()
22059

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
4I412U-100020A
In Commercial Distribution

  • 00840828158855 ()
21936

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
4I41UU-101003A
In Commercial Distribution

  • 00840828158831 ()
21924

  • Pillow speaker
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