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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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
No Description
Sarstedt Aktiengesellschaft & Co.KG
90.2064.122
In Commercial Distribution

  • 04038917793278 ()
90.2064.122

  • Laboratory container/microscope slide robotic transfer system IVD
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2630-9601-3 G
In Commercial Distribution

  • 04049016083283 ()


  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
InTENSity at Home OTC TENS device with 12 preset programs and 100 Intensity levels
COMPASS HEALTH BRANDS CORP.
E200-6R
In Commercial Distribution

  • 30092237619590 ()
  • 00092237619599 ()
  • 80092237619595 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation 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
No Description
TALLADIUM, INC.
19820-ATML-A3
In Commercial Distribution

  • D79119820ATMLA30 ()
19820-ATML-A3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19816-OFAML-D3
In Commercial Distribution

  • D79119816OFAMLD30 ()
19816-OFAML-D3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19816-ATML-D3
In Commercial Distribution

  • D79119816ATMLD30 ()
19816-ATML-D3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19816-ATML-A2
In Commercial Distribution

  • D79119816ATMLA20 ()
19816-ATML-A2

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19814-OFAML-D3
In Commercial Distribution

  • D79119814OFAMLD30 ()
19814-OFAML-D3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19814-ATML-C2
In Commercial Distribution

  • D79119814ATMLC20 ()
19814-ATML-C2

  • Dental appliance fabrication material, ceramic
Inogen At Home Stationary Concentrator, CE (10-06316-XX-XX)
Inogen, Inc.
CE
In Commercial Distribution

  • 00817131020148 ()
GS-100

  • Stationary oxygen concentrator
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
No Description
TALLADIUM, INC.
5147-MLAT-D3
In Commercial Distribution

  • D7915147MLATD30 ()
5147-MLAT-D3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-D2
In Commercial Distribution

  • D7915147MLATD20 ()
5147-MLAT-D2

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-C3
In Commercial Distribution

  • D7915147MLATC30 ()
5147-MLAT-C3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-C2
In Commercial Distribution

  • D7915147MLATC20 ()
5147-MLAT-C2

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-C1
In Commercial Distribution

  • D7915147MLATC10 ()
5147-MLAT-C1

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-B2
In Commercial Distribution

  • D7915147MLATB20 ()
5147-MLAT-B2

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-B1
In Commercial Distribution

  • D7915147MLATB10 ()
5147-MLAT-B1

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-A3.5
In Commercial Distribution

  • D7915147MLATA350 ()
5147-MLAT-A3.5

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-A3
In Commercial Distribution

  • D7915147MLATA30 ()
5147-MLAT-A3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5144-MLAT-D3
In Commercial Distribution

  • D7915144MLATD30 ()
5144-MLAT-D3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5144-MLAT-D2
In Commercial Distribution

  • D7915144MLATD20 ()
5144-MLAT-D2

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5144-MLAT-C3
In Commercial Distribution

  • D7915144MLATC30 ()
5144-MLAT-C3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5144-MLAT-C2
In Commercial Distribution

  • D7915144MLATC20 ()
5144-MLAT-C2

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5144-MLAT-C1
In Commercial Distribution

  • D7915144MLATC10 ()
5144-MLAT-C1

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5144-MLAT-A1
In Commercial Distribution

  • D7915144MLATA10 ()
5144-MLAT-A1

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19820-OFAML-D3
In Commercial Distribution

  • D79119820OFAMLD30 ()
19820-OFAML-D3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19820-ATML-D3
In Commercial Distribution

  • D79119820ATMLD30 ()
19820-ATML-D3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19820-ATML-D2
In Commercial Distribution

  • D79119820ATMLD20 ()
19820-ATML-D2

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19820-ATML-C3
In Commercial Distribution

  • D79119820ATMLC30 ()
19820-ATML-C3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19820-ATML-C2
In Commercial Distribution

  • D79119820ATMLC20 ()
19820-ATML-C2

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19820-ATML-C1
In Commercial Distribution

  • D79119820ATMLC10 ()
19820-ATML-C1

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19820-ATML-B3
In Commercial Distribution

  • D79119820ATMLB30 ()
19820-ATML-B3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19820-ATML-B1
In Commercial Distribution

  • D79119820ATMLB10 ()
19820-ATML-B1

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19820-ATML-A3.5
In Commercial Distribution

  • D79119820ATMLA350 ()
19820-ATML-A3.5

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19820-ATML-A2
In Commercial Distribution

  • D79119820ATMLA20 ()
19820-ATML-A2

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19814-ATML-D3
In Commercial Distribution

  • D79119814ATMLD30 ()
19814-ATML-D3

  • Dental appliance fabrication material, ceramic
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
No Description
ALIMED, INC.
1431
In Commercial Distribution

  • 00733657216899 ()
2970000240

  • Gel-filled chair cushion
The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
HEALTHY.IO LTD
WND PNT.EN.GEN
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272877 ()


  • Wound management image-analysis software
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
Gown, non-surgical, Level 2, grippers at neck, tie at waist, special color coded neckband, Size 2XL
Lac-Mac Limited
005DSBK-2XL
In Commercial Distribution

  • 00627755561169 ()

  • Height: 53 Inch
005DSBK-2XL

  • Isolation gown, reusable
Surgical Gown, Level 3, grippers at neck, tie at waist, special color coded neckband, Size 2XL
Lac-Mac Limited
005XXCE-2XL
In Commercial Distribution

  • 00627755561152 ()

  • Height: 57.25 Inch
005XXCE-2XL

  • Surgical gown, reusable
Surgical Gown, Level 4, grippers at neck, tie at waist, special color coded neckband, Size 2XL
Lac-Mac Limited
005XXBN-2XL
In Commercial Distribution

  • 00627755561145 ()

  • Height: 57.25 Inch
005XXBN-2XL

  • Surgical gown, reusable
Gown, non-surgical, Level 2, grippers at neck, tie at waist, special color coded neckband, Size XL
Lac-Mac Limited
005DSBK-XL
In Commercial Distribution

  • 00627755551160 ()

  • Height: 52 Inch
005DSBK-XL

  • Isolation gown, reusable
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