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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Frame Spectacle
Etnia Barcelona, Llc.
6 FLUX 51O CO
In Commercial Distribution

  • 18435685006280 ()
  • 08435685006283 ()


  • Spectacle frame
Frame Spectacle
Etnia Barcelona, Llc.
6 AURA 55O CO
In Commercial Distribution

  • 18435685004569 ()
  • 08435685004562 ()


  • Spectacle frame
sunglasses (non-prescriptionincluding photosensitive)
Etnia Barcelona, Llc.
5 EPIC 52S CO
In Commercial Distribution

  • 18435736076224 ()
  • 08435736076227 ()


  • Tinted non-prescription spectacles
Frame Spectacle
Etnia Barcelona, Llc.
5 EPIC 52D CO
In Commercial Distribution

  • 18435736076217 ()
  • 08435736076210 ()


  • Spectacle frame
Frame Spectacle
Etnia Barcelona, Llc.
5 BRUT31 47O CO
In Commercial Distribution

  • 18435736061992 ()
  • 08435736061995 ()


  • Spectacle frame
Axial length measurement probe with an integrated laser pointer for biometry: - Ensuring the acquisition in the visual axis - Increasing the patient cooperation - Accelerating the speed of acquisition of A scans
QUANTEL MEDICAL
TP-02-las
In Commercial Distribution

  • 03700542625101 ()


  • Ophthalmic ultrasound imaging transducer
No change in DI justified in the CO. No form fit function, model or version changes triggering a new DI
Ulthera, Inc.
CM1 Rev C, D, E
In Commercial Distribution

  • 00840763100384 ()


  • Mechanical skin contouring system motor
JAMSHIDI (TJ) BONE MARROW BIOPSY/ASPIRATION NEEDLE WITH MARROW ACQUISITION CRADLE 8G X 6
CAREFUSION 2200, INC
TJM6008
In Commercial Distribution

  • 50885403044593 ()
  • 10885403044595 ()

  • Length: 6 Inch
  • Needle Gauge: 8 Gauge
TJM6008

  • Bone marrow biopsy needle, single-use
JAMSHIDI (TJ) BONE MARROW BIOPSY/ASPIRATION NEEDLE WITH MARROW ACQUISITION CRADLE 8G X 4
CAREFUSION 2200, INC
TJM4008
In Commercial Distribution

  • 50885403044562 ()
  • 10885403044564 ()

  • Needle Gauge: 8 Gauge
  • Length: 4 Inch
TJM4008

  • Bone marrow biopsy needle, single-use
Jamshidi® Bone Marrow Biopsy/Aspiration Needle,With Marrow Acquisition Cradle, 11G x 10cm
CAREFUSION 2200, INC
MICH4011
In Commercial Distribution

  • 50885403103184 ()
  • 10885403103186 ()

  • Needle Gauge: 11 Gauge
  • Length: 4 Inch
MICH4011

  • Bone marrow biopsy procedure kit
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition Xmaru1524CF Master Plus OP
VATECH CO., LTD.
PHT-75CHS
In Commercial Distribution

  • 08800016400786 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Norav Telemetry ECG Acquisition Device NR2 for Telemetry Resting-ECG Monitoring with AHA type labelling.
NORAV MEDICAL LTD.
NR314T
In Commercial Distribution

  • 07290110254636 ()
NR314T-D-00U-02

  • Electrocardiographic ambulatory recorder
Norav Telemetry ECG Acquisition Device NR1 for Telemetry Resting-ECG Monitoring with AHA type labelling.
NORAV MEDICAL LTD.
NR314T
In Commercial Distribution

  • 07290110254629 ()
NR314T-D-00U-01

  • Electrocardiographic ambulatory recorder
Norav Telemetry ECG Acquisition Device NR2 for Telemetry Resting-ECG Monitoring with IEC type labelling.
NORAV MEDICAL LTD.
NR314T
In Commercial Distribution

  • 07290110254612 ()
NR314T-D-00E-02

  • Electrocardiographic ambulatory recorder
Norav Telemetry ECG Acquisition Device NR1 for Telemetry Resting-ECG Monitoring with IEC type labelling.
NORAV MEDICAL LTD.
NR314T
In Commercial Distribution

  • 07290110253332 ()
NR314T-D-00E-01

  • Electrocardiographic ambulatory recorder
Norav PC-ECG 1200 Series wireless Acquisition Device for Resting ECG with AHA type labelling.
NORAV MEDICAL LTD.
Blue ECG
In Commercial Distribution

  • 07290110250607 ()
  • 7290110250713 ()
BLUECG-D-00U-01

  • Electrocardiography telemetric monitoring system transmitter
ELI 280 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, UTK wireless receiver.
WELCH ALLYN, INC.
901095
In Commercial Distribution

  • 00732094261424 ()
UPG280-B-WAM-A

  • Electrocardiograph, professional, multichannel
ELI 280 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, UTK wireless receiver.
WELCH ALLYN, INC.
901000
In Commercial Distribution

  • 00732094261417 ()
UPG280-B-WAM-B

  • Electrocardiograph, professional, multichannel
XScribe 5 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, UTK wireless receiver.
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261264 ()


  • Electrocardiographic lead set, reusable
XScribe 5 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, UTK wireless receiver.
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261257 ()


  • Electrocardiographic lead set, reusable
PowerPICC SOLO2 HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Triple-Lumen) (with Microintroducer)
Bard Access Systems, Inc.
9395108QD
In Commercial Distribution

  • 10801741035903 ()
  • 00801741035906 ()

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

  • Peripherally-inserted central venous catheter
HF CONNECTION CABLE BIPO L 5M for bipolar resection, 2 PIN plug, Valleylab plug with RFID identification, reusable
Richard Wolf GmbH
8108253
In Commercial Distribution

  • 04055207063354 ()

  • Length: 5 Meter
8108253

  • Electrical-only medical device connection cable, reusable
HF CONNECTION CABLE BIPO L 3M for bipolar resection, 2 PIN plug, Valleylab plug with RFID identification, reusable
Richard Wolf GmbH
8108233
In Commercial Distribution

  • 04055207063347 ()

  • Length: 3 Meter
8108233

  • Electrical-only medical device connection cable, reusable
PEDERSON VAGINAL SPECULA FIG. 3, BLUE COATED, WITH SMOKE TUBE 120 X 25 MM, FOR HF-/ LASER SURGERY
Gimmi GmbH
GU.1012.03
In Commercial Distribution

  • 04049047654094 ()
GU.1012.03

  • Vaginal speculum, reusable
GRAVE VAGINAL SPECULA FIG. 3, BLUE COATED, WITH SMOKE TUBE 115 X 33 MM, FOR HF-/ LASER SURGERY
Gimmi GmbH
GU.1002.03
In Commercial Distribution

  • 04049047654049 ()
GU.1002.03

  • Vaginal speculum, reusable
GRAVE VAGINAL SPECULA FIG. 2, BLUE COATED, WITH SMOKE TUBE 95 X 35 MM, FOR HF-/ LASER SURGERY
Gimmi GmbH
GU.1002.02
In Commercial Distribution

  • 04049047654032 ()
GU.1002.02

  • Vaginal speculum, reusable
PEDERSON VAGINAL SPECULA FIG. 2, BLUE COATED, WITH SMOKE TUBE 100 X 22 MM, FOR HF-/ LASER SURGERY
Gimmi GmbH
GU.1012.02
In Commercial Distribution

  • 04049047654018 ()
GU.1012.02

  • Vaginal speculum, reusable
Ergonomic Highly Rigid Plastic Ring Handle With Ratchet And Ratchet Activating Release Lever Rotation Module And HF Connection
SONTEC INSTRUMENTS, INC.
2901-094
In Commercial Distribution

  • 00192896114074 ()


  • Laparoscopic surgery handle
HANDLE PISTOL SHAPED MONO with monopolar HF connection, for use with all insulated ERAGON outer sheath tubes, reusable
Richard Wolf GmbH
83930074
In Commercial Distribution

  • 04055207026625 ()
83930074

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
HANDLE PISTOL SHAPED MONO with monopolar HF connection, for use with all insulated ERAGON outer sheath tubes, reusable
Richard Wolf GmbH
83930073
In Commercial Distribution

  • 04055207026618 ()
83930073

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
MICASEPT HF-DRESSING AND GRASPING FORCEPS MONOPOLAR WITHOUT RATCHET
SONTEC INSTRUMENTS, INC.
20921-78
Not in Commercial Distribution

  • B09920921780 ()

  • 4.5mm Diameter
  • Length: 300 Millimeter


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
No Description
GLOBUS MEDICAL, INC.
SC2829-6-26
In Commercial Distribution

  • 10840843108283 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-6-23
In Commercial Distribution

  • 10840843108276 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-6-20
In Commercial Distribution

  • 10840843108269 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-6-12
In Commercial Distribution

  • 10840843108238 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-5-30
In Commercial Distribution

  • 10840843108214 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-5-26
In Commercial Distribution

  • 10840843108207 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-5-23
In Commercial Distribution

  • 10840843108191 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-5-20
In Commercial Distribution

  • 10840843108184 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-5-17
In Commercial Distribution

  • 10840843108177 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-5-14
In Commercial Distribution

  • 10840843108160 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-5-12
In Commercial Distribution

  • 10840843108153 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-5-10
In Commercial Distribution

  • 10840843108146 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-4-30
In Commercial Distribution

  • 10840843108139 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-4-26
In Commercial Distribution

  • 10840843108122 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-4-23
In Commercial Distribution

  • 10840843108115 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-4-20
In Commercial Distribution

  • 10840843108108 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-4-17
In Commercial Distribution

  • 10840843108092 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-4-14
In Commercial Distribution

  • 10840843108085 ()


  • Tibial insert
No Description
GLOBUS MEDICAL, INC.
SC2829-4-12
In Commercial Distribution

  • 10840843108078 ()


  • Tibial insert
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