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
VATECH CO., LTD.
PHT-65LHS
Not in Commercial Distribution

  • 08800016400380 ()


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

  • 08800016400366 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
PC-ECG Acquisition Device with Trigger, 5V operating voltage, FW7, ANALOG
NORAV MEDICAL LTD.
1200T
In Commercial Distribution

  • 07290110255046 ()
1200T2-D-00-06

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

  • 7290110250782 ()
  • 07290110252854 ()
1200M-D-00U-01

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

  • 07290110252847 ()
1200M-D-00E-01

  • Electrocardiographic signal amplifier
PC-ECG Wireless Acquisition Device for Resting-ECG with IEC type labelling
NORAV MEDICAL LTD.
BlueECG
In Commercial Distribution

  • 07290110250720 ()
BLUECG-D-00E-01

  • Electrocardiography telemetric monitoring system transmitter
No Description
BIOMET SPINE LLC
50-6594MP
In Commercial Distribution

  • 00880304948235 ()

  • TI VARIABLE LOCKING SCREW 5.0 X 40MM HF SEAT ASSY
50-6594MP

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
50-6593MP
In Commercial Distribution

  • 00880304948228 ()

  • TI VARIABLE LOCKING SCREW 5.0 X 35MM HF SEAT ASSY
50-6593MP

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
50-6592MP
In Commercial Distribution

  • 00880304948211 ()

  • TI VARIABLE LOCKING SCREW 5.0 X 30MM HF SEAT ASSY
50-6592MP

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
50-6591MP
In Commercial Distribution

  • 00880304948204 ()

  • TI VARIABLE LOCKING SCREW 5.0 X 25MM HF SEAT ASSY
50-6591MP

  • Bone-screw internal spinal fixation system, non-sterile
5mm 32cm Andrew Babcock Forcep, Non-Locking, Insulated, Stainless Steel Handle, Rotating With HF Pos
Surgical Direct, Inc.
SD88882
In Commercial Distribution

  • B382SD888820 ()
SD88882

  • Laparoscopic tissue manipulation forceps/working-channel
PowerPICC SOLO HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray
Bard Access Systems, Inc.
9395108Q
In Commercial Distribution

  • 10801741035897 ()
  • 00801741035890 ()

  • Catheter Gauge: 5 French
  • Length: 55 Centimeter
9395108Q

  • Peripherally-inserted central venous catheter
HF Monopolar Cable, with Big Bovie Plug, for use with Surgical Direct Flexible Electrodes
Surgical Direct, Inc.
SD1261998U
In Commercial Distribution

  • B382SD1261998U0 ()
SD1261998U

  • Endoscope sheath, reusable
5mm 33cm Metzenbaum Scissor, Curved, Rotatable, with Insulated, Non Locking HF Handle, Flush Port
Surgical Direct, Inc.
SD146792.100
In Commercial Distribution

  • B382SD1467921000 ()
SD146792.100

  • Flexible endoscopic tissue manipulation forceps, single-use
5mm 33cm Metzenbaum Scissor, Curved, Rotatable, with Insulated, Non Locking HF Handle, Flush Port
Surgical Direct, Inc.
SD146792
In Commercial Distribution

  • B382SD1467920 ()
SD146792

  • Flexible endoscopic tissue manipulation forceps, single-use
Supercut Scissors, Straight Single Action Jaw, Monopolar HF Port, Non-Ratchet Handle with Rotation Lock
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
35-302
Not in Commercial Distribution

  • H834353021 ()
  • 10381780152835 ()


  • Rigid endoscopic scissors, reusable
Tapered Dissecting Forceps, Monopolar HF Port, Dual Action Jaw, Non-Ratchet Handle with Rotation Lock
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
35-204
Not in Commercial Distribution

  • H834352041 ()
  • 10381780152156 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
MARYLAND Dissector, Curved Dual Action Jaws, Monopolar HF Port, Non-Ratchet Handle with Rotation Lock
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
35-201
Not in Commercial Distribution

  • H834352011 ()
  • 10381780152149 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
MONOPOLAR SUCTION / IRRIGATION HANDLE PISTOL WITH SLIDING VALVE HF PLUG AND UNIVERSAL TUBE CONNECTOR
Gimmi GmbH
T.0130.00
In Commercial Distribution

  • 04049047097198 ()
T.0130.00

  • Electrosurgical handpiece, reusable
Jet Port Plus Silicone Kit HF with 8.4F x 750 mm Attachable Silicone Catheter
PFM MEDICAL INCORPORATED
616.463.1080-A
In Commercial Distribution

  • 07640110981788 ()
  • 07640110987643 ()


  • Vascular port/catheter
Tita Jet Light PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
PFM MEDICAL INCORPORATED
616.362.2080-A
In Commercial Distribution

  • 07640110981276 ()
  • 07640110987513 ()


  • Vascular port/catheter
Jet Port Plus PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter
PFM MEDICAL INCORPORATED
616.363.2080-A
In Commercial Distribution

  • 07640110981283 ()
  • 07640110987506 ()


  • Vascular port/catheter
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.1
In Commercial Distribution

  • 04260521363527 ()


  • Dental milling system, CAD/CAM, chairside
  • CAD/CAM software
The Ceramill M-Plant module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. Ceramill M-Plant is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.1
In Commercial Distribution

  • 04260521363619 ()


  • Dental milling system, CAD/CAM, chairside
  • CAD/CAM software
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.2
In Commercial Distribution

  • 04260521363534 ()


  • Dental milling system, CAD/CAM, chairside
  • CAD/CAM software
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.0
In Commercial Distribution

  • 04260521363510 ()


  • CAD/CAM software
  • Dental milling system, CAD/CAM, chairside
ECG monitor 1 to 2 adaptor cable/MECG+FECG/3-lead/060-522+039/0.18+0.18M/Tracelogix Co
Unimed Medical Supplies, Inc.
TL145-00A-136
In Commercial Distribution

  • 06945664885355 ()


  • Electrical-only medical device connection cable, reusable
LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873761601 ()
70335-000208

  • Physiologic-monitoring defibrillation system
LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873761595 ()
70335-000209

  • Physiologic-monitoring defibrillation system
Forceps Cornea MISHIMA Original Model
Diamatrix
S-9B
In Commercial Distribution

  • 00813059019783 ()
S-9B

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Scissors Spring Handle Type Curved Short Pointed
Diamatrix
S-511CSS
In Commercial Distribution

  • 00813059019776 ()
S-511CSS

  • Intraocular scissors, conventional-hinge, reusable
Forceps Cornea and Suturing Type C Ultra Fine 0.12mm
Diamatrix
M-5R
In Commercial Distribution

  • 00813059019769 ()
M-5R

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Forceps Suturing and Tying Ultra Fine,- Forceps without teeth
Diamatrix
M-171R
In Commercial Distribution

  • 00813059019752 ()
M-171R

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Tanito Micro Hook for Trabeculotomy, Ab Interno, Left
Diamatrix
M-2215L
In Commercial Distribution

  • 00813059018502 ()
M-2215L

  • Ocular hook/spatula/manipulator, reusable
Tanito Micro Hook for Trabeculotomy, Ab Interno, Right
Diamatrix
M-2215R
In Commercial Distribution

  • 00813059018496 ()
M-2215R

  • Ocular hook/spatula/manipulator, reusable
Tanito Micro Hook for Trabeculotomy, Ab Interno, Straight
Diamatrix
M-2215S
In Commercial Distribution

  • 00813059018489 ()
M-2215S

  • Ocular hook/spatula/manipulator, reusable
No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution

  • 06975031820320 ()


  • Dental casting non-noble alloy
No Description
Hansol Medical Co.
NEW HANSOL Cupping cup_No. 5
In Commercial Distribution

  • 08809118711059 ()


  • Cupping therapy device
No Description
Hansol Medical Co.
NEW HANSOL Cupping cup_No. 4
In Commercial Distribution

  • 08809118711042 ()


  • Cupping therapy device
No Description
Hansol Medical Co.
NEW HANSOL Cupping cup_No. 3
In Commercial Distribution

  • 08809118711035 ()


  • Cupping therapy device
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