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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System Scaling Pro Line 502-1
E.M.S. Electro Medical Systems S.A.
e
In Commercial Distribution

  • 07613353085988 ()
FS-241

  • Ultrasonic dental scaling/debridement system
Handpiece 120° Anthracite
E.M.S. Electro Medical Systems S.A.
e
In Commercial Distribution

  • 07613353063559 ()
EL-185/A

  • Dental abrasive air jet system handpiece
Bottle 20g powder AIR-FLOW SOFT
E.M.S. Electro Medical Systems S.A.
e
In Commercial Distribution

  • 07613353055363 ()
DV-071/S

  • Dental abrasive powder
Instrument HPL3
E.M.S. Electro Medical Systems S.A.
e
In Commercial Distribution

  • 07613353029722 ()
DS-075

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Instrument Sinus Lift N°1
E.M.S. Electro Medical Systems S.A.
e
In Commercial Distribution

  • 07613353002640 ()
DS-101

  • Dental ultrasonic surgical system handpiece tip
miniEndo
E.M.S. Electro Medical Systems S.A.
e
In Commercial Distribution

  • 07613353002619 ()
FT-081DM

  • Ultrasonic dental scaling/debridement system
Calf Sty 3 Sz 9 Sterile
Aart
E
In Commercial Distribution

  • B490502309E0 ()
502-309E

  • Silicone-block tissue reconstructive material
Szr - Calf Sty 3 Sz 9 NS
Aart
E
In Commercial Distribution

  • B4905023092E0 ()
502-309-2E

  • Silicone-block tissue reconstructive material
Calf Sty 3 Sz 8 Sterile
Aart
E
In Commercial Distribution

  • B490502308E0 ()
502-308E

  • Silicone-block tissue reconstructive material
Szr - Calf Sty 3 Sz 8 NS
Aart
E
In Commercial Distribution

  • B4905023082E0 ()
502-308-2E

  • Silicone-block tissue reconstructive material
Calf Sty 3 Sz 7 Sterile
Aart
E
In Commercial Distribution

  • B490502307E0 ()
502-307E

  • Silicone-block tissue reconstructive material
Szr - Calf Sty 3 Sz 7 NS
Aart
E
In Commercial Distribution

  • B4905023072E0 ()
502-307-2E

  • Silicone-block tissue reconstructive material
Calf Sty 3 Sz 6 Sterile
Aart
E
In Commercial Distribution

  • B490502306E0 ()
502-306E

  • Silicone-block tissue reconstructive material
Szr - Calf Sty 3 Sz 6 NS
Aart
E
In Commercial Distribution

  • B4905023062E0 ()
502-306-2E

  • Silicone-block tissue reconstructive material
Calf Sty 3 Sz 5 Sterile
Aart
E
In Commercial Distribution

  • B490502305E0 ()
502-305E

  • Silicone-block tissue reconstructive material
Szr - Calf Sty 3 Sz 5 NS
Aart
E
In Commercial Distribution

  • B4905023052E0 ()
502-305-2E

  • Silicone-block tissue reconstructive material
Calf Sty 3 Sz 4 Sterile
Aart
E
In Commercial Distribution

  • B490502304E0 ()
502-304E

  • Silicone-block tissue reconstructive material
Szr - Calf Sty 3 Sz 4 NS
Aart
E
In Commercial Distribution

  • B4905023042E0 ()
502-304-2E

  • Silicone-block tissue reconstructive material
Calf Sty 3 Sz 3 Sterile
Aart
E
In Commercial Distribution

  • B490502303E0 ()
502-303E

  • Silicone-block tissue reconstructive material
Szr - Calf Sty 3 Sz 3 NS
Aart
E
In Commercial Distribution

  • B4905023032E0 ()
502-303-2E

  • Silicone-block tissue reconstructive material
Calf Sty 3 Sz 2 Sterile
Aart
E
In Commercial Distribution

  • B490502302E0 ()
502-302E

  • Silicone-block tissue reconstructive material
Szr - Calf Sty 3 Sz 2 NS
Aart
E
In Commercial Distribution

  • B4905023022E0 ()
502-302-2E

  • Silicone-block tissue reconstructive material
Calf Sty 3 Sz 1 Sterile
Aart
E
In Commercial Distribution

  • B490502301E0 ()
502-301E

  • Silicone-block tissue reconstructive material
Szr - Calf Sty 3 Sz 1 NS
Aart
E
In Commercial Distribution

  • B4905023012E0 ()
502-301-2E

  • Silicone-block tissue reconstructive material
Calf Sty 3 Sz 0 Sterile
Aart
E
In Commercial Distribution

  • B490502300E0 ()
502-300E

  • Silicone-block tissue reconstructive material
Szr - Calf Sty 3 Sz 0 NS
Aart
E
In Commercial Distribution

  • B4905023002E0 ()
502-300-2E

  • Silicone-block tissue reconstructive material
Szr - Pectoral Sty 3 Sz 2 R NS
Aart
E
In Commercial Distribution

  • B49050030262E0 ()
500-302-6-2E

  • Pectoral implant
Szr - Pectoral Sty 3 Sz 2 L NS
Aart
E
In Commercial Distribution

  • B49050030252E0 ()
500-302-5-2E

  • Pectoral implant
Szr - Pectoral Sty 3 Sz 1 R NS
Aart
E
In Commercial Distribution

  • B49050030162E0 ()
500-301-6-2E

  • Pectoral implant
Szr - Pectoral Sty 3 Sz 1 L NS
Aart
E
In Commercial Distribution

  • B49050030152E0 ()
500-301-5-2E

  • Pectoral implant
No Description
Merit Medical Systems, Inc.
E
In Commercial Distribution

  • 00884450610879 ()

  • Expanded Stent Length (mm)-70 mm
  • Nominal Stent Diameter (mm)-23 mm
MAXX-237

  • Polymer-metal oesophageal stent
No Description
Merit Medical Systems, Inc.
E
In Commercial Distribution

  • 00884450610855 ()

  • Expanded Stent Length (mm)-150 mm
  • Nominal Stent Diameter (mm)-23 mm
MAXX-2315

  • Polymer-metal oesophageal stent
No Description
Merit Medical Systems, Inc.
E
In Commercial Distribution

  • 00884450610831 ()

  • Nominal Stent Diameter (mm)-23 mm
  • Expanded Stent Length (mm)-120 mm
MAXX-2312

  • Polymer-metal oesophageal stent
No Description
Merit Medical Systems, Inc.
E
In Commercial Distribution

  • 00884450610817 ()

  • Nominal Stent Diameter (mm)-23 mm
  • Expanded Stent Length (mm)-100 mm
MAXX-2310

  • Polymer-metal oesophageal stent
No Description
Merit Medical Systems, Inc.
E
In Commercial Distribution

  • 00884450610794 ()

  • Expanded Stent Length (mm)-70 mm
  • Nominal Stent Diameter (mm)-19 mm
MAXX-197

  • Polymer-metal oesophageal stent
No Description
Merit Medical Systems, Inc.
E
In Commercial Distribution

  • 00884450610770 ()

  • Expanded Stent Length (mm)-150 mm
  • Nominal Stent Diameter (mm)-19 mm
MAXX-1915

  • Polymer-metal oesophageal stent
No Description
Merit Medical Systems, Inc.
E
In Commercial Distribution

  • 00884450610756 ()

  • Nominal Stent Diameter (mm)-19 mm
  • Expanded Stent Length (mm)-120 mm
MAXX-1912

  • Polymer-metal oesophageal stent
No Description
Merit Medical Systems, Inc.
E
In Commercial Distribution

  • 00884450610732 ()

  • Expanded Stent Length (mm)-100 mm
  • Nominal Stent Diameter (mm)-19 mm
MAXX-1910

  • Polymer-metal oesophageal stent
No Description
Jiangsu HanHeng Medical Technology Co., Ltd
E
In Commercial Distribution

  • 06973697810730 ()


  • General-purpose absorbent tip applicator/swab, single-use
No Description
Merit Medical Systems, Inc.
E
In Commercial Distribution

  • 10884450846572 ()
  • 00884450846575 ()

  • Tubing Length (in/cm)-20" (51 cm)
TS120

  • Basic intravenous administration set, noninvasive
ShangRing Male Circumcision Device Self-locking
Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd.
E
In Commercial Distribution

  • 26939550822320 ()
  • 16939550822323 ()
  • 86939550822322 ()


  • Surgical penis clamp, single-use
IntelliVue GuardianSoftware is a software-only product. It is the core of the Guardian General Care Solution, which provides fully customizable workflow support for automated vital signs taking, early warning scoring, patient deteroration detection, caregiver notification and care escalation for medical/surgical care, ED waiting/triage and other general care areas. It also mediates the data flow between the devices and hospital systems. Guardian Software license options listed enable desired features and capabilities for specified number of patients, clients, selected measurement technologies as well as required connectivity to hospital systems.
Philips Medizin Systeme Böblingen GmbH
E
In Commercial Distribution

  • 00884838094253 ()
866009

  • Medical equipment clinical data interfacing software
Allergen-Specific IgE - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10708840
In Commercial Distribution

  • 00630414982939 ()
L2KUN6(D)

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
Quantitative determination of IgE in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446129
In Commercial Distribution

  • 00842768008078 ()
  • 00842768018947 ()
OQTG15

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of immunoglobulin E in human serum and plasma (heparin or EDTA) on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445902
In Commercial Distribution

  • 00842768006173 ()
  • 00842768020087 ()
K7054

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry
The DRG IgE ELISA is intended for the quantitative determination of immunoglobulin E in human serum. This assay is to be used for the assessment of hypersensitive and allergic reactions in patients.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-1788
In Commercial Distribution

  • 04048474017885 ()
EIA-1788

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
The DRG IgE ELISA is intended for the quantitative determination of immunoglobulin E in human serum. This assay is to be used for the assessment of hypersensitive and allergic reactions in patients.
DRG International Inc
EIA-1788
In Commercial Distribution

  • 00840239017888 ()
EIA-1788

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
QC Sets and Panels: Helix Elite™ Comprehensive Enteric Bacterial Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8231
In Commercial Distribution

  • 70845357042704 ()
8231

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Extended Enteric Bacterial Verification Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8191
In Commercial Distribution

  • 70845357041363 ()
8191

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
KIT, OPTIGEN US Environmental 36 (40ND)
Minaris Medical America, Inc.
85168
In Commercial Distribution

  • 00813382012178 ()
85168

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
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