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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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No Description
TALLADIUM, INC.
19814-ATML-B3
In Commercial Distribution

  • D79119814ATMLB30 ()
19814-ATML-B3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19814-ATML-A1
In Commercial Distribution

  • D79119814ATMLA10 ()
19814-ATML-A1

  • Dental appliance fabrication material, ceramic
SET of: 09120073930750, CNAP® Monitor 500, Main Unit including quick Guide 09120073930767, CNAP® controller set, incl. 09120073930774 CNAP® Controller and 09120073930088 Fixture for CNAP® controller, adapter between 09120073930774 CNAP® Controller and 09120073930354 CNAP® forearm fixing cuff 09120073930354, CNAP® forearm fixing cuff, for fixing 09120073930774 CNAP® Controller 09120073930095, CNAP® cable, 2.5m; interface 09120073930774 CNAP® controller to 09120073930750 CNAP® Monitor 500 09120073930125, CNAP® double finger cuff "large", sensor with Extended Lifecycle (150h) 09120073930163, CNAP® double finger cuff "medium", sensor with Extended Lifecycle (150h) 09120073930200, CNAP® double finger cuff "small", sensor with Extended Lifecycle (150h) 09120073930026, AUX: Analog out connector, connector for data analog output 09120073930033, BP Wave Out: CNAP® transducer cable, Unit; grey; adapter to interface cable 09120073930293, Operator's Manual, 09120073930668, CNAP® Component Organizer Set for CNAP® Monitor, 09120073930798 CNAP® double finger cuff mounting bracket together with 09120073930781 CNAP® controller mounting bracket NBP cuffs: 10840935102236, All Purpose, General, Large Adult, 98-0099-08, 20-FMA-15450 10840935102168, All Purpose, General, Adult 98-0097-10, 20-FMA-15350 10840935102113, All Purpose, General, Small Adult, 98-0095-09, 20-FMA-15250 10840935102052, All Purpose, General, Child, 98-0093-06, 20-FMA-15150 Patient Hose, 3 Meter, Rectus Fittings, 98-0028-00, 20-FMA-05050 Power cord USA Standard, 20-HEKA-01017, primary cord to external mains adapter External mains adapter, Manufacturer: M+R Multitronik GmbH, Niels-Bohr-Ring 28, 23568 Lübeck, Germany, phone: +49 451 60 99 5 0 Thermal paper, 20-HVZU-00258
CNSystems Medizintechnik AG
V1.4
Not in Commercial Distribution

  • 09120073930743 ()
21-FHCN-15500

  • Noninvasive haemodynamic monitoring system
Aperio ePathology IVD System AT Turbo, includes; AT Turbo IVD, eSlide Manager and eIHC 510(k) Cleared Image Analysis Kit 2500
LEICA BIOSYSTEMS IMAGING, INC
23ATTIVD-2500
In Commercial Distribution

  • 00815477020068 ()

  • Device Size Text, specify:


  • Multi-modality clinical specimen analysis system IVD
Inogen At Home Stationary Concentrator, NCE (10-05345-XX-XX)
Inogen, Inc.
NCE
In Commercial Distribution

  • 00817131020131 ()
GS-100

  • Stationary oxygen concentrator
For the quantitative determination of human alpha-1 anti-trypsin (Alpha-1 AT) in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-001
Not in Commercial Distribution

  • 00816426020009 ()
KAI-001

  • Trypsin-alpha-1-antitrypsin complex (elastase) IVD, reagent
Inogen At Home Stationary Concentrator, CE (10-06316-XX-XX)
Inogen, Inc.
CE
In Commercial Distribution

  • 00817131020148 ()
GS-100

  • Stationary oxygen concentrator
No Description
Modern Dental Laboratory (DG) Co., Ltd.
188
In Commercial Distribution

  • 06972677871891 ()
  • 06972677871884 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
  • Orthodontic retainer
No Description
Modern Dental Laboratory (DG) Co., Ltd.
186
In Commercial Distribution

  • 06972677871877 ()
  • 06972677871860 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
  • Orthodontic retainer
Surgical Gown, Level 4, grippers at neck, tie at waist, special color coded neckband, Size 4XL
Lac-Mac Limited
005XXBN-4XL
In Commercial Distribution

  • 00627755581143 ()

  • Height: 59.25 Inch
005XXBN-4XL

  • Surgical gown, reusable
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