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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HF BIPOLAR CONNECTING CABLE L 5M for KLS-Martin generators, M-Version, reusable
Richard Wolf GmbH
8108251
Not in Commercial Distribution

  • 04055207000915 ()

  • Length: 5 Meter
8108.251

  • Electrical-only medical device connection cable, reusable
HF BIPOLAR CONNECTING CABLE L 3M for KLS-Martin generators, M-Version, reusable
Richard Wolf GmbH
8108231
Not in Commercial Distribution

  • 04055207000892 ()

  • Length: 3 Meter
8108.231

  • Electrical-only medical device connection cable, reusable
Unit connection cable for connecting data acquisition unit
NIHON KOHDEN AMERICA, INC.
YS-096P3
In Commercial Distribution

  • 00841983102837 ()
YS-096P3

  • General-purpose multi-parameter bedside monitor
Unit connection cable for connecting data acquisition unit
NIHON KOHDEN AMERICA, INC.
YS-096P2
In Commercial Distribution

  • 00841983102820 ()
YS-096P2

  • General-purpose multi-parameter bedside monitor
Unit connection cable for connecting data acquisition unit
NIHON KOHDEN CORPORATION
YS-096P3
In Commercial Distribution

  • 04931921114735 ()
YS-096P3

  • General-purpose multi-parameter bedside monitor
Unit connection cable for connecting data acquisition unit
NIHON KOHDEN CORPORATION
YS-096P2
In Commercial Distribution

  • 04931921114728 ()
YS-096P2

  • General-purpose multi-parameter bedside monitor
EPAD Acquisition white right NMJ with ground cable
SAFEOP SURGICAL, INC.
EPAD
Not in Commercial Distribution

  • 00851641007176 ()
200010

  • Evoked-potential graphic recording system
EPAD Acquisition red left short no erbs cable
SAFEOP SURGICAL, INC.
EPAD
Not in Commercial Distribution

  • 00851641007169 ()
100512

  • Evoked-potential graphic recording system
EPAD Acquisition white right short no erbs cable
SAFEOP SURGICAL, INC.
EPAD
Not in Commercial Distribution

  • 00851641007152 ()
100513

  • Evoked-potential graphic recording system
SafeOp Neural Informatix System Cable, Left Acquisition (Red)
ALPHATEC SPINE, INC.
100833
In Commercial Distribution

  • 00190376235493 ()


  • Electrical-only medical device connection cable, single-use
SafeOp Neural Informatix System Cable, Right Acquisition (White)
ALPHATEC SPINE, INC.
100832
In Commercial Distribution

  • 00190376235486 ()


  • Electrical-only medical device connection cable, single-use
Gamma Camera Workstation for Acquisition, Reviewing and Processing
MiE medical imaging electronics GmbH
SCINTRON
In Commercial Distribution

  • 04260484140050 ()


  • Nuclear medicine system operator console, multi-purpose
ALPHA MULTISTORE ACQUISITION BOX HD INCLUSIVE SOFTWARE "PERSONAL"
Gimmi GmbH
S.2046.60 HD
In Commercial Distribution

  • 04049047653516 ()
S.2046.60 HD

  • Endoscopic video imaging system
WAM Wireless Acquisition Module without lead wires, INMETRO
WELCH ALLYN, INC.
901095
Not in Commercial Distribution

  • 00732094272253 ()
30012-019-65

  • Electrocardiograph, professional, multichannel
SPINAL SHEET W/QCM 3 SPECIAL - 34X34 1PLY STD SUP W/REIN CO
STANDARD TEXTILE CO., INC.
95280252
In Commercial Distribution

  • 00634916005363 ()
  • 10634916005360 ()
95280252

  • Patient surgical drape, reusable
5mm Maryland Dissector, Curved, Diamond Serrated, Double Action Standard Length, with Non-Locking Co
Surgical Direct, Inc.
SD8990-900
In Commercial Distribution

  • B382SD89909000 ()
SD8990-900

  • Laparoscopic tissue manipulation forceps/working-channel
LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,12L,WIFI/CELL/LN/CPRIN,STD,BT
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873765616 ()
70335-000042

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

  • 00883873766279 ()
70335-000035

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

  • 00883873765685 ()
70335-000037

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

  • 00883873765678 ()
70335-000038

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

  • 00883873765654 ()
70335-000039

  • Physiologic-monitoring defibrillation system
The BPro® device is designed to be worn like a wristwatch and to function as a blood pressure monitor.
HEALTHSTATS INTERNATIONAL PTE LTD
T6200 Series
Not in Commercial Distribution

  • 08885014410104 ()


  • Blood pressure ambulatory recorder
The BPro® BT is used to capture the pulse wave from the radial artery.
HEALTHSTATS INTERNATIONAL PTE LTD
T6200 series
In Commercial Distribution

  • 08885014410005 ()


  • Blood pressure ambulatory recorder
STARR CO SET TORT/DEPO_GLD CO- Frame Material: TR-90 / Metal - Rectangle Office Wear /Gold Frame Clip On - Lens Technology: Base: DigiTec® Clip: TriLenium® 7 Polarized lens- Sunglasses
Eagle Eyes
22016
In Commercial Distribution

  • 00810712013492 ()
22016

  • Tinted non-prescription spectacle lens
No Description
W.H. Holden, Inc.
10-5119HF
In Commercial Distribution

  • D928105119HF0 ()


  • Paranasal sinus curette
No Description
W.H. Holden, Inc.
10-5117HF
In Commercial Distribution

  • D928105117HF0 ()


  • Paranasal sinus curette
No Description
W.H. Holden, Inc.
10-5114HF
In Commercial Distribution

  • D928105114HF0 ()


  • Paranasal sinus curette
No Description
W.H. Holden, Inc.
10-7201H/O
In Commercial Distribution

  • D928107201HO0 ()


  • Scalpel handle, reusable
No Description
W.H. Holden, Inc.
10-5435HF
In Commercial Distribution

  • D928105435HF0 ()


  • Periosteal elevator, reusable
No Description
W.H. Holden, Inc.
10-4301H
In Commercial Distribution

  • D928104301H0 ()


  • Dental elevator, tooth/root
No Description
W.H. Holden, Inc.
20-1002HF
In Commercial Distribution

  • D928201002HF0 ()


  • Surgical mallet
No Description
W.H. Holden, Inc.
10-5162HF
In Commercial Distribution

  • D928105162HF0 ()


  • Dental osteotome
No Description
W.H. Holden, Inc.
10-5116HF
In Commercial Distribution

  • D928105116HF0 ()


  • Paranasal sinus curette
No Description
W.H. Holden, Inc.
10-5115HF
In Commercial Distribution

  • D928105115HF0 ()


  • Paranasal sinus curette
No Description
TALLADIUM, INC.
1952D3
In Commercial Distribution

  • D7911952D30 ()


  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
1952D2
In Commercial Distribution

  • D7911952D20 ()


  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
1952C4
In Commercial Distribution

  • D7911952C40 ()


  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
1952C3
In Commercial Distribution

  • D7911952C30 ()


  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
1952C2
In Commercial Distribution

  • D7911952C20 ()


  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
1952C1
In Commercial Distribution

  • D7911952C10 ()


  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
1952B4
In Commercial Distribution

  • D7911952B40 ()


  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
1952B3
In Commercial Distribution

  • D7911952B30 ()


  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
1951C4
In Commercial Distribution

  • D7911951C40 ()


  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
1951C3
In Commercial Distribution

  • D7911951C30 ()


  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
1951C2
In Commercial Distribution

  • D7911951C20 ()


  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
1951C1
In Commercial Distribution

  • D7911951C10 ()


  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
1951B3
In Commercial Distribution

  • D7911951B30 ()


  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
1951B2
In Commercial Distribution

  • D7911951B20 ()


  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
1951B
In Commercial Distribution

  • D7911951B0 ()


  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
1951A4
In Commercial Distribution

  • D7911951A40 ()


  • Dental appliance fabrication material, ceramic
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