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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MICTEC HF FLAT ELECTRODE WITH LATERAL SLOTS AND CENTRAL HOLE CURVED WITH CONNECTION TO SUCTION-IRRIGATION VALVES
SONTEC INSTRUMENTS, INC.
20947-11-002
In Commercial Distribution


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


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
TEM GRASPING FORCEPS Ø 4.8MM WL 410MM right curved, with monopolar HF connection, TL 535mm, reusable
Richard Wolf GmbH
8840623
Not in Commercial Distribution

  • 04055207020982 ()

  • Length: 410 Millimeter
  • Outer Diameter: 4.8 Millimeter
8840.623

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
TEM GRASPING FORCEPS Ø 4.8MM WL 410MM left curved, with monopolar HF connection, TL 533mm, reusable
Richard Wolf GmbH
8840624
Not in Commercial Distribution

  • 04055207020999 ()

  • Length: 410 Millimeter
  • Outer Diameter: 4.8 Millimeter
8840.624

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
PowerPICC HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Basic Tray (Triple-Lumen) (with Microintroducer)
Bard Access Systems, Inc.
9385118Q
In Commercial Distribution

  • 10801741035811 ()
  • 00801741035814 ()

  • Catheter Gauge: 5 French
  • Length: 55 Centimeter
9385118Q

  • Peripherally-inserted central venous catheter
This device is designed to be used with the endoscope holder "UniARM" manufactured by Mitaka Kohki Co., Ltd.
MITAKA KOHKI CO., LTD.
UH-1015U
In Commercial Distribution

  • 04589698450497 ()


  • Surgical instrument assist arm system, power-adjusted
This device is designed to be used with the endoscope holder "UniARM" manufactured by Mitaka Kohki Co., Ltd.
MITAKA KOHKI CO., LTD.
UH-510U
In Commercial Distribution

  • 04589698450480 ()


  • Surgical instrument assist arm system, power-adjusted
This device is designed to be used with the endoscope holder "UniARM" manufactured by Mitaka Kohki Co., Ltd.
MITAKA KOHKI CO., LTD.
UMP
In Commercial Distribution

  • 04589698450411 ()


  • Surgical instrument assist arm system, power-adjusted
Medava N95 Fold Style Respirator. Disposable Surgical N95 Respirator. Manufactured by Louis M. Gerson Co., Inc. for Medava.
LOUIS M. GERSON CO.
USAMN95F50
In Commercial Distribution

  • 00850052096434 ()
  • 00850052096427 ()
  • 00860006025793 ()
USAMN95F50

  • Surgical/medical respirator, non-antimicrobial, single-use
Vital Signs™ cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft
AirLife Finland Oy
9446-910
In Commercial Distribution

9446-910

  • Injectate temperature probe
ELI 380 upgrade to enable use with the WAM Wireless Acquisition Module. Upgrade includes WAM Wireless Acquisition Module, 12 lead AHA lead set, set of 10 adapter clips.
WELCH ALLYN, INC.
901000
In Commercial Distribution

  • 00732094261356 ()
UPG380-B-WAM-A

  • Electrocardiograph, professional, multichannel
ELI 380 upgrade to enable use with the WAM Wireless Acquisition Module. Upgrade includes WAM Wireless Acquisition Module, 12 lead IEC lead set, set of 10 adapter clips.
WELCH ALLYN, INC.
901095
In Commercial Distribution

  • 00732094261349 ()
UPG380-B-WAM-B

  • Electrocardiograph, professional, multichannel
A standalone HeRO monitor for two infants
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000234 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware
A HeRO System for the private room
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000227 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware
No Description
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000210 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware
Server based HeRO System
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000203 ()


  • Neonatal/paediatric heart rate monitoring hardware
  • Neonatal/paediatric heart rate monitoring application software
Magphan® 172, Complete Magphan® including 20cm spherical housing, 20cm cylindrical housing, 10cm test cube and cases.
Providus Holdings, Inc.
SMR172
In Commercial Distribution

  • 00812266030925 ()
SMR172

  • MRI phantom, test object
  • Multi-modality therapeutic radiation phantom, test object
Magphan® 140, 10cm sphere with support disk.
Providus Holdings, Inc.
SMR140
In Commercial Distribution

  • 00812266030901 ()
SMR140

  • MRI phantom, test object
  • Multi-modality therapeutic radiation phantom, test object
Magphan® 100, Complete Magphan® including 20cm spherical housing, 10cm test cube and case.
Providus Holdings, Inc.
SMR100
In Commercial Distribution

  • 00812266030895 ()
SMR100

  • MRI phantom, test object
  • Multi-modality therapeutic radiation phantom, test object
Magphan® 170, Complete Magphan® including 20cm cylindrical housing, 10cm test cube and case.
Providus Holdings, Inc.
SMR170
In Commercial Distribution

  • 00812266030918 ()
SMR170

  • MRI phantom, test object
  • Multi-modality therapeutic radiation phantom, test object
LiquiPhil™ End-to-End Pelvis, includes pelvis form, two 10cm ovoid tumor vessels and permanent storage case
Providus Holdings, Inc.
TLP260
In Commercial Distribution

  • 00812266030772 ()
TLP260

  • MRI phantom, test object
  • Multi-modality therapeutic radiation phantom, test object
The device is an optical impression system. It is used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-aided design (CAD) and computer-aided manufacturing (CAM) of dental restorative prosthetic devices.
CEFLA SOCIETA' COOPERATIVA
NewTom IOS
In Commercial Distribution

  • 08033837932970 ()
70960000

  • Intraoral optical scanning system
  • Dental milling system, CAD/CAM, chairside
Norav Receiver for wireless PC-ECG Acquisition Device Norav 1200W with ECG Trigger Output.
Norav Medical GmbH
1200WR
In Commercial Distribution

  • 04260498566907 ()
1200WR-D-00-09

  • Electrocardiographic signal amplifier
Safety Deluxe bone Marrow Biopsy/Aspiration Tray with Snare-it marrow acquisition & Aspiration needle
ROBERT BUSSE & CO., INC.
988
Not in Commercial Distribution

  • 10849233013831 ()
  • 00849233013834 ()
988

  • Bone marrow biopsy procedure kit
J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition Cannula 11g x4"
ROBERT BUSSE & CO., INC.
628
In Commercial Distribution

  • 00849233013179 ()
  • 10849233013176 ()
628

  • Bone marrow biopsy needle, single-use
Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru2301CF)
VATECH CO., LTD.
VistaPano
Not in Commercial Distribution

  • 08800016401868 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition
VATECH CO., LTD.
PHT-35LHS
In Commercial Distribution

  • 08800016401318 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT/CEPH Image Acquisition Xmaru1404CF-Plus, Xmaru2602CF
VATECH CO., LTD.
PHT-30CSS
In Commercial Distribution

  • 08800016401103 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1404CF/W-Pano_R1/MASTER)
VATECH CO., LTD.
PHT-30LFO
Not in Commercial Distribution

  • 08800016400618 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1314CF/G2/MASTER)
VATECH CO., LTD.
PHT-65LHS
In Commercial Distribution

  • 08800016400595 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition (Xmaru1501CF-PLUS / Xmaru2602CF)
VATECH CO., LTD.
VistaPano S Ceph
In Commercial Distribution

  • 08800016401967 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition
VATECH CO., LTD.
PHT-65LHS
In Commercial Distribution

  • 08800016400410 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition
VATECH CO., LTD.
PHT-65LHS
Not in Commercial Distribution

  • 08800016400397 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition
VATECH CO., LTD.
PHT-35LHS
Not in Commercial Distribution

  • 08800016400373 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru2301CF)
VATECH CO., LTD.
ProVecta S-Pan
In Commercial Distribution

  • 08800016400311 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Digital X-ray Imaging System functioning Pano/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / 910SGA)
VATECH CO., LTD.
PCH-2500
Not in Commercial Distribution

  • 08800016400298 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Digital X-ray Imaging System functioning Pano/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / 1210SGA)
VATECH CO., LTD.
PCH-2500
Not in Commercial Distribution

  • 08800016400281 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru2301CF)
VATECH CO., LTD.
PCH-2500
In Commercial Distribution

  • 08800016400274 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1501CF / Xmaru1524CF(H))
VATECH CO., LTD.
PHT-60CFO
In Commercial Distribution

  • 08800016400113 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1501CF / Xmaru1524CF(V))
VATECH CO., LTD.
PHT-60CFO
Not in Commercial Distribution

  • 08800016400076 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
JAMSHIDI (TJ) BONE MARROW BIOPSY/ASPIRATION NEEDLE WITH MARROW ACQUISITION CRADLE 11G X6
CAREFUSION 2200, INC
TJM6011
In Commercial Distribution

  • 50885403044609 ()
  • 10885403044601 ()

  • Length: 6 Inch
  • Needle Gauge: 11 Gauge
TJM6011

  • Bone marrow biopsy needle, single-use
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