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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Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition Xmaru1404CF-Plus
VATECH CO., LTD.
PHT-30CSS
In Commercial Distribution

  • 08800016401097 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1404CF)
VATECH CO., LTD.
PHT-35LHS
Not in Commercial Distribution

  • 08800016400588 ()


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

  • 08800016400007 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
PC-ECG Wireless Acquisition Device for Stress-Test ECG with AHA type labelling
NORAV MEDICAL LTD.
1200W2
In Commercial Distribution

  • 07290110252076 ()
1200W2-D-00U-01

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

  • 07290110250522 ()
1200W2-D-00E-01

  • Electrocardiography telemetric monitoring system transmitter
Single channel ECG Acquisition Device with Analogue Output, MIDI, 35Hz Filter
NORAV MEDICAL LTD.
ECGUSB1
In Commercial Distribution

  • 07290110250959 ()
  • 7290110253004 ()
ECGUSB1A-K-00-01

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

  • 07290110250829 ()
1200S-D-00E-01

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

  • 07290110250812 ()
  • 7290110250843 ()
1200S-D-00U-01

  • Electrocardiographic signal amplifier
PodSKAN is an advanced high frequency type X-Ray system designed for superior image quality with powerful 2.8KW generator and very low leakage radiation. The system houses two microprocessors, one for control/supervisory functions and another one man-machine/User interface. It can be easily plugged into 16A Wall socket with 120 VAC or 240 VAC, 50/60 Hz.. The technology incorporates feedback circuits to ensure highest accuracy & reproducibility of X-Ray output.
SKANRAY TECHNOLOGIES LIMITED
303-002665-0
In Commercial Distribution

  • 08904269415105 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
W.H. Holden, Inc.
70-5164HTIN
In Commercial Distribution

  • D928705164HTIN0 ()


  • Periodontal curette
No Description
W.H. Holden, Inc.
70-5164HF
In Commercial Distribution

  • D928705164HF0 ()


  • Periodontal curette
No Description
W.H. Holden, Inc.
10-6102SH/O
In Commercial Distribution

  • D928106102SHO0 ()


  • Dental suction system cannula, reusable
No Description
W.H. Holden, Inc.
10-5435HFDLC
In Commercial Distribution

  • D928105435HFDLC0 ()


  • Periosteal elevator, reusable
No Description
W.H. Holden, Inc.
10-5312HF
In Commercial Distribution

  • D928105312HF0 ()


  • Nasal chisel
No Description
W.H. Holden, Inc.
10-5199-10BHF
In Commercial Distribution

  • D92810519910BHF0 ()


  • Dental osteotome set
No Description
W.H. Holden, Inc.
10-5106-4HF
In Commercial Distribution

  • D9281051064HF0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
20-0030H/O
In Commercial Distribution

  • D928200030HO0 ()


  • Periosteal elevator, reusable
No Description
W.H. Holden, Inc.
20-1160-2CH
In Commercial Distribution

  • D9282011602CH0 ()


  • Gauze packer
No Description
W.H. Holden, Inc.
20-0709H/O
In Commercial Distribution

  • D928200709HO0 ()


  • Hand-held surgical retractor, reusable
X-Ray System, Podiatry DR Ready (70kVp,10mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR410i
In Commercial Distribution

  • 00817100020148 ()
PXS-710

  • Stationary basic diagnostic x-ray system, digital
The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
2500
In Commercial Distribution

  • 04251285200227 ()


  • Reverse-osmosis water purification system
The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
2000
In Commercial Distribution

  • 04251285200210 ()


  • Reverse-osmosis water purification system
The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
1500
In Commercial Distribution

  • 04251285200203 ()


  • Reverse-osmosis water purification system
The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
1000
In Commercial Distribution

  • 04251285200197 ()


  • Reverse-osmosis water purification system
The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
500
In Commercial Distribution

  • 04251285200180 ()


  • Reverse-osmosis water purification system
Implantable Cardioverter Defibrillator DR
BOSTON SCIENTIFIC CORPORATION
D533
In Commercial Distribution

  • 00802526588310 ()


  • Dual-chamber implantable defibrillator
Implantable Cardioverter Defibrillator VR
BOSTON SCIENTIFIC CORPORATION
D532
In Commercial Distribution

  • 00802526588280 ()


  • Single-chamber implantable defibrillator
AIX1000 Rapid Plasma Reagin (RPR) Analyzer (refurbished)
Gold Standard Diagnostics Corporation
00400R
In Commercial Distribution

  • B35000400R0 ()
00400R

  • Agglutination assay digital imaging reader/analyser IVD
  • Treponema pallidum reagin antibody IVD, kit, agglutination
AIX1000 Rapid Plasma Reagin (RPR) Analyzer
Gold Standard Diagnostics Corporation
00400
In Commercial Distribution

  • B350004000 ()


  • Treponema pallidum reagin antibody IVD, kit, agglutination
  • Agglutination assay digital imaging reader/analyser IVD
FOOTSWITCH 2 PEDALS L 5M FOR HF SURGERY GENERATOR 400KHZ, with fixed connection cable, reusable
Richard Wolf GmbH
2260021
In Commercial Distribution

  • 04055207063330 ()

  • Length: 5 Meter
2260021

  • Foot-switch, electrical
Ergonomic carbon handle w. ratchet, ratchet with on / off system, HF connector male 45° angled
ELMED INCORPORATED
R52555-40-10
In Commercial Distribution

  • 00198506073892 ()
R52555-40-10

  • Laparoscopic surgical procedure kit, non-medicated, reusable
Biopsy-Forceps, Ø5mm, WL 330mm, double action jaw, shaft insulated, metal handle insulated, HF- connection, detachable
Hermann Medizintechnik GmbH
H40-533-641
In Commercial Distribution

  • 04059453003539 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
10mm Bariatric Length Spoon Forceps, Comfort Grip, Carbon Fiber, On/Off Ratchet, Rotating, HF Post
Surgical Direct, Inc.
SD16608-14
In Commercial Distribution

  • B382SD16608140 ()

  • Length: 36 Centimeter
  • Outer Diameter: 10 Millimeter
SD16608-14

  • Endoscope sheath, reusable
5mm 33cm Maryland Dissector,18mm Curved Jaw, Rotatable, with Insulated, Non Locking HF Handle, Flus
Surgical Direct, Inc.
SD881322L
In Commercial Distribution

  • B382SD881322L0 ()
SD881322L

  • Laparoscopic tissue manipulation forceps/working-channel
5mm 33cm Maryland Dissector, Standard 20mm Curved Jaw, Rotatable, with Insulated, Non Locking HF Han
Surgical Direct, Inc.
SD881322b
In Commercial Distribution

  • B382SD881322B0 ()
SD881322b

  • Laparoscopic tissue manipulation forceps/working-channel
5mm 33cm Maryland Dissector, Standard 18mm Curved Jaw, Rotatable, with Insulated, Non Locking HF Han
Surgical Direct, Inc.
SD881322
In Commercial Distribution

  • B382SD8813220 ()
SD881322

  • Laparoscopic tissue manipulation forceps/working-channel
5mm DeBakey Curved Tissue Forceps, Non- Locking, Insulated, Stainless Steel Handle, Rotating with HF Port
Surgical Direct, Inc.
SD88922
In Commercial Distribution

  • B382SD889220 ()
SD88922

  • Laparoscopic tissue manipulation forceps/working-channel
Tita Jet Light II PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
PFM MEDICAL INCORPORATED
616.368.2080-A
In Commercial Distribution

  • 07640110981757 ()
  • 07640110987988 ()


  • Vascular port/catheter
Jet Port Plus II PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
PFM MEDICAL INCORPORATED
616.367.2080-A
In Commercial Distribution

  • 07640110981702 ()
  • 07640110987940 ()


  • Vascular port/catheter
T-Port PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter and Silicone Plugs
PFM MEDICAL INCORPORATED
616.365.2081-A
In Commercial Distribution

  • 07640110981603 ()
  • 07640110987537 ()


  • Vascular port/catheter
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