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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UCP Centralizer with cement restrictor, 14C
UNITED ORTHOPEDIC CORP.
1907-3014
In Commercial Distribution

  • 04711605569347 ()

  • 14C
1907-3014

  • Metal-on-polyethylene total hip prosthesis
UCP Centralizer with cement restrictor, 12C
UNITED ORTHOPEDIC CORP.
1907-3012
In Commercial Distribution

  • 04711605569330 ()

  • 12C
1907-3012

  • Metal-on-polyethylene total hip prosthesis
UCP Centralizer with cement restrictor, 10C
UNITED ORTHOPEDIC CORP.
1907-3010
In Commercial Distribution

  • 04711605569323 ()

  • 10C
1907-3010

  • Metal-on-polyethylene total hip prosthesis
UCP Centralizer with cement restrictor, 8C
UNITED ORTHOPEDIC CORP.
1907-3008
In Commercial Distribution

  • 04711605569316 ()

  • 8C
1907-3008

  • Metal-on-polyethylene total hip prosthesis
Reusable Probe with Irrigation Holes.
APPLIED MEDICAL RESOURCES CORPORATION
C6211
Not in Commercial Distribution

  • 00607915117139 ()

  • Length: 45 Centimeter
  • Outer Diameter: 5 Millimeter


  • Surgical irrigation/aspiration handpiece, reusable
Reusable Probe with Pool Tip.
APPLIED MEDICAL RESOURCES CORPORATION
C6205
Not in Commercial Distribution

  • 00607915117085 ()

  • Length: 33 Centimeter
  • Outer Diameter: 5 Millimeter


  • Surgical irrigation/aspiration handpiece, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-162-018
In Commercial Distribution

  • 09348215061920 ()


  • Fluted surgical drill bit, reusable
BEQ-HMOD 30000-USA Pediatric Quadrox iD
DATASCOPE CORP.
BEQ-TOP 8512
In Commercial Distribution

  • 00607567213449 ()
709000624

  • Cardiopulmonary bypass system blood tubing set
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-162-019
In Commercial Distribution

  • 09348215061937 ()


  • Fluted surgical drill bit, reusable
No Description
SIZEWISE RENTALS, L.L.C.
NPT 4 Family
In Commercial Distribution

  • 00845699008162 ()


  • Foam bed mattress
No Description
EVIDENT CORPORATION
IX3-SVR
In Commercial Distribution



  • Inverted-stage light microscope
BEQ-HMOD 70000-USA Adult Quadrox iD, Better Bladder 3/8, BEQ-RF32 RotaFlow, CDI Sat Cell 3/8" System 100, Gas Filter
DATASCOPE CORP.
BEQ-TOP 13505
Not in Commercial Distribution

  • 00607567205536 ()
701065817

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 70000 USA Adult Quadrox Softshell venous Reser. 1900ml with connector Gas Filter
DATASCOPE CORP.
BEQ-TOP 47501
Not in Commercial Distribution

  • 00607567207561 ()
709000031

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 30000-USA Pediatric Quadrox Softshell Venous Reser 800 ml Better Bladder BEQ-RF32 RotaFlow CDI Sat Cell 1/4" Blood Microfilter Systes Prebypass filter w/o Vent Posous Media Gas Filter Temperature Probe
DATASCOPE CORP.
BEQ-TOP 31000
Not in Commercial Distribution

  • 00607567205192 ()
701052843

  • Cardiopulmonary bypass system blood tubing set
BO-VHK 31000 Venous Res. Pediatric (MACE), BEQ-RF32 RotaFlow
DATASCOPE CORP.
BEQ-T 16403
Not in Commercial Distribution

  • 00607567205130 ()
701065315

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 70000 Softshell venous reser Better Bladder BEQ-RF32 CDI Sat Cell Blood Microfilter System Prebypass Filter
DATASCOPE CORP.
BEQ-TOP 35300
Not in Commercial Distribution

  • 00607567203075 ()
70105506

  • Cardiopulmonary bypass system blood tubing set
BEQ HMOD 30000 BEQ-RF32 Pediatric Temp Probe
DATASCOPE CORP.
BEQ-TOP 6604
Not in Commercial Distribution

  • 00607567202580 ()
701052163

  • Cardiopulmonary bypass system blood tubing set
No Description
XIROS LTD
202-3008
Not in Commercial Distribution

  • 05060267130716 ()
n/a

  • Exploratory blunt needle, single-use
No Description
W.H. Holden, Inc.
10-7114
In Commercial Distribution

  • D9281071140 ()


  • Surgical soft-tissue manipulation forceps, alligator, reusable
No Description
W.H. Holden, Inc.
10-5953-8-4
In Commercial Distribution

  • D928105954100 ()


  • Dental osteotome
No Description
W.H. Holden, Inc.
10-5953-8-4
In Commercial Distribution

  • D928105954080 ()


  • Dental osteotome
No Description
W.H. Holden, Inc.
10-5953-8-4
In Commercial Distribution

  • D928105954060 ()


  • Dental osteotome
No Description
W.H. Holden, Inc.
10-5532LM-1
In Commercial Distribution

  • D928105532LM10 ()


  • Dental cheek retractor, professional, reusable
Prefiltration Drawer, an optional medical device accessory to the Tablo® Hemodialysis System
Outset Medical, Inc.
PN-0006813
In Commercial Distribution

  • 00850001011303 ()


  • Combination water purification system
Prefiltration Drawer (Packaged), an optional medical device accessory to the Tablo® Hemodialysis System
Outset Medical, Inc.
PN-0006988
In Commercial Distribution

  • 00850001011297 ()


  • Combination water purification system
Surface electrodes for Electromyography with Pattern Recognition controller - Michelangelo Hand with Axon Elbow
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-24
In Commercial Distribution

  • 00850004850480 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode
Surface electrodes for Electromyography with Pattern Recognition controller - Michelangelo Hand with Axon Wrist with Axon Elbow
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-23
In Commercial Distribution

  • 00850004850473 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode
Surface electrodes for Electromyography with Pattern Recognition controller - Michelangelo Hand with Axon Wrist
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-22
In Commercial Distribution

  • 00850004850466 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode
Surface electrodes for Electromyography with Pattern Recognition controller - Michelangelo Hand
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-21
In Commercial Distribution

  • 00850004850459 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode
Surface electrodes for Electromyography with Pattern Recognition controller - Espire Pro/Hybrid (Hand without grips without wrist)
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-20
In Commercial Distribution

  • 00850004850442 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode
Surface electrodes for Electromyography with Pattern Recognition controller - Espire Pro/Hybrid (Hand with grips without wrist) - Bebionic (Steeper)
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-18-2
In Commercial Distribution

  • 00850004850411 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode
Surface electrodes for Electromyography with Pattern Recognition controller - Espire Pro/Hybrid (Hand with grips without wrist) - TASKA
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-18-1
In Commercial Distribution

  • 00850004850404 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode
Surface electrodes for Electromyography with Pattern Recognition controller - Espire Pro/Hybrid (Hand with grips with wrist) - Bebionic (Steeper)
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-17-2
In Commercial Distribution

  • 00850004850374 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode
Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand with grips without Wrist) - iLimb
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-10-3
In Commercial Distribution

  • 00850004850343 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode
Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand with grips without Wrist) - Bebionic (Steeper)
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-10-2
In Commercial Distribution

  • 00850004850336 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode
Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand with grips without Wrist) - TASKA
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-10-1
In Commercial Distribution

  • 00850004850329 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode
Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand with grips with Wrist) - iLimb
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-9-3
In Commercial Distribution

  • 00850004850305 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode
Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand with grips with Wrist) - Bebionic (Steeper)
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-9-2
In Commercial Distribution

  • 00850004850299 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode
Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand with grips with Wrist) - TASKA
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-9-1
In Commercial Distribution

  • 00850004850282 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode
Surface electrodes for Electromyography with Pattern Recognition controller - Hand and Wrist (with grips) - iLimb
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-3-3
In Commercial Distribution

  • 00850004850268 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode
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