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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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N13C5 Transducer - 05704916000196

Neonatal Cephalic, Pediatric, Intraoperative (neuro), Intraoperative
Bk Medical ApS
9062
In Commercial Distribution

  • 05704916000196 ()


  • Surgical ultrasound imaging transducer

X12C4 Transducer - 05704916000110

Intraoperative
Bk Medical ApS
9026
In Commercial Distribution

  • 05704916000110 ()


  • Surgical ultrasound imaging transducer

I12C5b Transducer - 05704916000103

Intraoperative, Musculoskeletal (conventional), Peripheral Vessel (peripheral vascular)
Bk Medical ApS
9024
In Commercial Distribution

  • 05704916000103 ()


  • Surgical ultrasound imaging transducer

I14C5T Transducer - 05704916000059

Intraoperative imaging, Abdominal imaging
Bk Medical ApS
9016
In Commercial Distribution

  • 05704916000059 ()


  • Surgical ultrasound imaging transducer

I14C5I Transducer - 05704916000042

Intraoperative, Pediatrics Musculoskeletal Pediatric Peripheral vascular Interventional Procedures
Bk Medical ApS
9015
In Commercial Distribution

  • 05704916000042 ()


  • Surgical ultrasound imaging transducer

X18L5s Transducer - 05704916000028

"Intraoperative imaging, Peripheral Vessel (Peripheral Vascular), Small Organ (Small Parts), Musculoskeletal (Superficial and Conventional) imaging"
Bk Medical ApS
9009
In Commercial Distribution

  • 05704916000028 ()


  • Surgical ultrasound imaging transducer

Rob12C4 - 05704916001599

The Rob12C4 drop-in transducer enables unique access to complex organs and difficult-to-access anatomy during robotic-assisted procedures.
Bk Medical ApS
9096
In Commercial Distribution

  • 05704916001599 ()


  • Surgical ultrasound imaging transducer

Burr-Hole Transducer - 05704916000660

Intraoperative Neuro imaging (Neurosurgery), Intraoperative imaging
Bk Medical ApS
8863
In Commercial Distribution

  • 05704916000660 ()


  • Surgical ultrasound imaging transducer

Craniotomy Transducer - 05704916000653

Interoperative Neuro imaging (Neurosurgery), Intraoperative imaging, Pediatrics imaging, Neonatal Cephalic imaging.
Bk Medical ApS
8862
In Commercial Distribution

  • 05704916000653 ()


  • Surgical ultrasound imaging transducer

Rigid Laparoscopic Transducer - 05704916000615

Intraoperative
Bk Medical ApS
8836
In Commercial Distribution

  • 05704916000615 ()


  • Surgical ultrasound imaging transducer

ProART Robotic “Drop-In” Transducer - 05704916000592

Intraoperative imaging
Bk Medical ApS
8826
In Commercial Distribution

  • 05704916000592 ()


  • Surgical ultrasound imaging transducer

Intraoperative Biplane Transducer - 05704916000585

Intraoperative imaging
Bk Medical ApS
8824
In Commercial Distribution

  • 05704916000585 ()


  • Surgical ultrasound imaging transducer

T-Shaped Intraoperative Transducer - 05704916000523

Intraoperative imaging, Abdominal imaging
Bk Medical ApS
8816
In Commercial Distribution

  • 05704916000523 ()


  • Surgical ultrasound imaging transducer

Intraoperative Transducer - 05704916000516

Intraoperative imaging, Pediatrics imaging
Bk Medical ApS
8815
In Commercial Distribution

  • 05704916000516 ()


  • Surgical ultrasound imaging transducer

“Hockey Stick” Transducer - 05704916000493

Intraoperative imaging, Peripheral Vessel (Peripheral Vascular), Musculoskeletal imaging, Small Organ (Small Parts)
Bk Medical ApS
8809
In Commercial Distribution

  • 05704916000493 ()


  • Surgical ultrasound imaging transducer

4-Way Laparoscopic Transducer - 05704916000448

Intraoperative imaging
Bk Medical ApS
8666-RF
In Commercial Distribution

  • 05704916000448 ()


  • Surgical ultrasound imaging transducer

N11C5s Transducer - 05704916000202

Intraoperative (neuro) imaging, Intraoperative imaging
Bk Medical ApS
9063
In Commercial Distribution

  • 05704916000202 ()


  • Surgical ultrasound imaging transducer

L16-4Hs Transducer(FDA-SJM) - 06903053039727

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
120-023009-00
In Commercial Distribution

  • 06903053039727 ()


  • Surgical ultrasound imaging transducer

HUMANSCAN - 08809476810241

L3-9i-RS Ultrasound Probe
HUMANSCAN CO.,LTD
5721640
In Commercial Distribution

  • 08809476810241 ()
500395

  • Surgical ultrasound imaging transducer

HUMANSCAN - 08809476810234

L3-9i-D Ultrasound Probe
HUMANSCAN CO.,LTD
5491310
In Commercial Distribution

  • 08809476810234 ()
500395

  • Surgical ultrasound imaging transducer
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