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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Biopsy Forceps, Oval Fenestrated Jaws, Monopolar HF Port, Single Action, Non-Ratchet Handle with Rotation Lock
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
35-402
Not in Commercial Distribution

  • H834354021 ()
  • 10381780152217 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Biopsy Punch, Serrated Lower Jaw, Monopolar HF Port, Single Action, Non-Ratchet Handle with Rotation Lock
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
35-401
Not in Commercial Distribution

  • H834354011 ()
  • 10381780152200 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Bullet Nose Dissecting Forceps, Dual Action Jaws, Monopolar HF Port, Non-Ratchet Handle with Rotation Lock
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
35-203
Not in Commercial Distribution

  • H834352031 ()
  • 10381780152194 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Tapered MARYLAND Dissector, Curved Double Action Jaws, Monopolar HF Port, Non-Ratchet Handle with Rotation Lock
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
35-200
Not in Commercial Distribution

  • H834352001 ()
  • 10381780152187 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Supercut METZENBAUM Scissors, Curved Dual Action Jaws, Monopolar HF Port, Non-Ratchet Handle with Rotation Lock
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
35-300
Not in Commercial Distribution

  • H834353001 ()
  • 10381780152828 ()


  • Rigid endoscopic scissors, reusable
PowerPICC HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Triple-Lumen)
Bard Access Systems, Inc.
9385108QD
In Commercial Distribution

  • 10801741035804 ()
  • 00801741035807 ()

  • Catheter Gauge: 5 French
  • Length: 55 Centimeter
9385108QD

  • Peripherally-inserted central venous catheter
PowerPICC HF Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet 5F Maximal Barrier Tray
Bard Access Systems, Inc.
1385108QD
In Commercial Distribution

  • 10801741034654 ()
  • 00801741034657 ()

  • Catheter Gauge: 5 French
  • Length: 55 Centimeter
1385108QD

  • Peripherally-inserted central venous catheter
PowerPICC HF Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Full Tray (5F) (Triple-Lumen)
Bard Access Systems, Inc.
1385108Q
In Commercial Distribution

  • 10801741034647 ()
  • 00801741034640 ()

  • Length: 55 Centimeter
  • Catheter Gauge: 5 French
1385108Q

  • Peripherally-inserted central venous catheter
AIR-FLOW® handy 3.0 PERIO / PLUS Premium Adapter KaVo
E.M.S. Electro Medical Systems S.A.
FT-225#HF/A/007
In Commercial Distribution

  • 07613353202262 ()


  • Dental abrasive air jet system handpiece
MIDDLE EAR ANALYZER. Flute HF is a middle ear analyzer, capable of performing: tympanometry and acoustic reflex tests in sequence and automatically, ETF (Eustachian Tube Function) test for both intact and perforated eardrums, and tympanometry at 1000 Hz. Flute HF has, in addition, an integrated thermal printer.
INVENTIS SRL
FLUTE HF WITH PRINTER
In Commercial Distribution

  • 08054187380457 ()
10410

  • Impedance audiometer
HIDREX USA DVP1000 Iontophoresis Device Package Hand/Foot (Aluminum Electrode Plates, US Type A Plug)
HIDREX GmbH
DVP1000 Package HF AL
In Commercial Distribution

  • 04250571300610 ()
ION17110US

  • Hyperhidrosis iontophoresis system
HIDREX USA DP450 Iontophoresis Device Package Hand/Foot (Aluminum Electrode Plates, US Type A Plug)
HIDREX GmbH
DP450 Package HF AL
In Commercial Distribution

  • 04250571300719 ()
ION17451US

  • Hyperhidrosis iontophoresis system
Fastline Disposable N95 Particulate Respirator. Manufactured by Louis M. Gerson Co., Inc. for The Sherwin Williams Company.
LOUIS M. GERSON CO.
FDM30
In Commercial Distribution

  • 00044585817301 ()
  • 00764423027777 ()


  • Surgical/medical respirator, non-antimicrobial, single-use
The ATLAS Workstation is a computer that runs the Data Acquisition Software.
NEURALYNX, INC.
ATLAS Workstation
In Commercial Distribution

  • 00850011306949 ()
31-0004-0000

  • Electroencephalographic monitoring system
long-term EEG fixed and/or ambulatory acquisition/recording device (32 EEG channels)
MICROMED SPA
SD LTM 32 PLUS
In Commercial Distribution

  • 08033928120903 ()


  • Patient monitoring system module, electroencephalographic
long-term EEG fixed and/or ambulatory acquisition/recording device (64 EEG channels)
MICROMED SPA
SD LTM 64 PLUS
In Commercial Distribution

  • 08033928120897 ()


  • Patient monitoring system module, electroencephalographic
long-term EEG fixed and/or ambulatory acquisition/recording device (64 EEG channels)
MICROMED SPA
SD LTM 64 EXPRESS
In Commercial Distribution

  • 08033928120750 ()


  • Patient monitoring system module, electroencephalographic
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1501CF / Xmaru1524CF)
VATECH CO., LTD.
PHT-60CFO
In Commercial Distribution

  • 08800016400533 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition
VATECH CO., LTD.
PCH-30CS
In Commercial Distribution

  • 08800016400458 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition
VATECH CO., LTD.
PCH-30CS
In Commercial Distribution

  • 08800016400434 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1501CF / Xmaru1215CF)
VATECH CO., LTD.
PHT-6500
In Commercial Distribution

  • 08800016400229 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1501CF / Xmaru0712CF)
VATECH CO., LTD.
PHT-6500
In Commercial Distribution

  • 08800016400182 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1501CF / Xmaru1215CF)
VATECH CO., LTD.
PHT-60CFO
In Commercial Distribution

  • 08800016400038 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Norav Wireless ECG Acquisition Device NR3 for Resting-ECG with IEC type labelling.
NORAV MEDICAL LTD.
NR1207-E
In Commercial Distribution

  • 07290110255381 ()
NR1207E-D-00E-06

  • Electrocardiographic ambulatory recorder
PC-ECG Wireless Acquisition Device (RFID3) for Stress-Test ECG with AHA type labelling
NORAV MEDICAL LTD.
1200W2
In Commercial Distribution

  • 07290110253745 ()
1200W2-D-00U-03

  • Electrocardiography telemetric monitoring system transmitter
PC-ECG Wireless Acquisition Device (RFID2) for Stress-Test ECG with AHA type labelling
NORAV MEDICAL LTD.
1200W2
In Commercial Distribution

  • 07290110253738 ()
1200W2-D-00U-02

  • Electrocardiography telemetric monitoring system transmitter
PC-ECG Wireless Acquisition Device (RFID3) for Stress-Test ECG with IEC type labelling
NORAV MEDICAL LTD.
1200W2
In Commercial Distribution

  • 07290110253721 ()
1200W2-D-00E-03

  • Electrocardiography telemetric monitoring system transmitter
PC-ECG Wireless Acquisition Device (RFID2) for Stress-Test ECG with IEC type labelling
NORAV MEDICAL LTD.
1200W2
In Commercial Distribution

  • 07290110253714 ()
1200W2-D-00E-02

  • Electrocardiography telemetric monitoring system transmitter
Norav Wireless ECG Acquisition Device NR1 for Resting-ECG with IEC type labelling.
NORAV MEDICAL LTD.
NR1207-E
In Commercial Distribution

  • 07290110253097 ()
NR1207E-D-00E-01

  • Electrocardiographic ambulatory recorder
Norav Wireless ECG Acquisition Device NR2 for Resting-ECG with AHA type labelling.
NORAV MEDICAL LTD.
NR1207-E
In Commercial Distribution

  • 07290110254773 ()
NR1207E-D-00U-02

  • Electrocardiographic ambulatory recorder
Norav Wireless ECG Acquisition Device NR1 for Resting-ECG with AHA type labelling.
NORAV MEDICAL LTD.
NR1207-E
In Commercial Distribution

  • 07290110254766 ()
NR1207E-D-00U-01

  • Electrocardiographic ambulatory recorder
Norav Wireless ECG Acquisition Device NR2 for Resting-ECG with IEC type labelling.
NORAV MEDICAL LTD.
NR1207-E
In Commercial Distribution

  • 07290110254759 ()
NR1207E-D-00E-02

  • Electrocardiographic ambulatory recorder
PC-ECG Acquisition Device for Stress-Test ECG recordings with AHA type labelling BMS.
NORAV MEDICAL LTD.
1200S
In Commercial Distribution

  • 07290110254117 ()
1200S-D-03U-01

  • Electrocardiographic signal amplifier
PC-ECG Acquisition Device for Stress-Test ECG recordings with IEC type labelling BMS.
NORAV MEDICAL LTD.
1200S
In Commercial Distribution

  • 07290110254100 ()
1200S-D-03E-01

  • Electrocardiographic signal amplifier
WAM wireless acquisition module with 10 wire IEC lead set with clips
WELCH ALLYN, INC.
901095
In Commercial Distribution

  • 00732094272130 ()
41000-031-53

  • Electrocardiograph, professional, multichannel
AM12 acquisition module with 10 wire IEC lead set with banana plugss
WELCH ALLYN, INC.
901095
In Commercial Distribution

  • 00732094272109 ()
41000-032-51

  • Electrocardiograph, professional, multichannel
Qty 1 - 15610003 - Emerald S Scanner (US) Qty 1 - 15600141 - Emerald S Scanner Accessories Qty 1 - 15693001 Cariosity Tip
D4D TECHNOLOGIES, LLC
15600140 Emerald S Scanner Kit, Cariosity, US
Not in Commercial Distribution

  • 00858809006170 ()
  • 00858809006224 ()


  • Dental caries detector, optical induced fluorescence
  • Dental milling system, CAD/CAM, chairside
T-Port LP PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
PFM MEDICAL INCORPORATED
616.366.2081-A
In Commercial Distribution

  • 07640110981696 ()
  • 07640110987476 ()


  • Vascular port/catheter
Biopsy Forceps, Tooth On Each Jaw, Monopolar HF Port, Single Action, Non-Ratchet Handle with Rotation Lock
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
35-400
Not in Commercial Distribution

  • H834354001 ()
  • 10381780152170 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
MICTEC HF FLAT ELECTRODE WITH LATERAL SLOTS AND CENTRAL HOLE CURVED WITH CONNECTION TO SUCTION-IRRIGATION VALVES
SONTEC INSTRUMENTS, INC.
20947-11-002
Not in Commercial Distribution

  • B09920947110020 ()

  • 10mm Valve Connection
  • Length: 300 Millimeter
  • 7mm 30° Tip


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
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