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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BI8000 Biosite Plus 60psi Transparent Needleless Neutral Valve
MACLIN POWER, INC.
BI8000
In Commercial Distribution

  • B134BI80001 ()
  • B134BI80000 ()
BI8000

  • Intravenous administration tubing extension set
Handheld Direct Drive Cable Trainer.
Beyond Power Inc.
HDDT-A1,Beyond Power Voltra I
In Commercial Distribution

  • 06977069493330 ()


  • Body/limb elastic exerciser
No Description
Zoll Medical Corporation
1110-0013-01
In Commercial Distribution

  • 00847946098964 ()


  • Rechargeable professional automated external defibrillator
PUMP CARTRIDGE, BLOOD, 10 PER CASE (IPN 0040-0051)
Zoll Medical Corporation
1110-0051
In Commercial Distribution

  • 00847946021603 ()


  • Rechargeable professional automated external defibrillator
PUMP CARTRIDGE, CRYSTALLOID/COLLOID, 10 PER CASE (IPN 0040-0050)
Zoll Medical Corporation
1110-0050
In Commercial Distribution

  • 00847946021597 ()


  • Rechargeable professional automated external defibrillator
Power Knee incl 3Y warranty
OSSUR AMERICAS, INC.
PKA10003
In Commercial Distribution

  • 05690967648749 ()
PKA10003

  • Motorized external knee prosthesis
Power Knee incl 2Y warranty
OSSUR AMERICAS, INC.
PKA10001
In Commercial Distribution

  • 05690967648381 ()
PKA10001

  • Motorized external knee prosthesis
POWER KNEE BATT CHARGER LOANER
OSSUR AMERICAS, INC.
PK22100
Not in Commercial Distribution

  • 05690967603427 ()
PK22100

  • Motorized external knee prosthesis
POWERLOGIC II TRAINING SOFTWAR
OSSUR AMERICAS, INC.
PK218001
Not in Commercial Distribution

  • 05690967586669 ()
PK218001

  • Motorized external knee prosthesis
POWERLOGIC II FULL ACCESS
OSSUR AMERICAS, INC.
PK218000
Not in Commercial Distribution

  • 05690967586652 ()
PK218000

  • Motorized external knee prosthesis
POWER KNEE G2 KIT NA TRIAL
OSSUR AMERICAS, INC.
PKN120037
Not in Commercial Distribution

  • 05690967585839 ()
PKN120037

  • Motorized external knee prosthesis
POWER KNEE G2 KIT NA 5 yr warr
OSSUR AMERICAS, INC.
PKN120017
Not in Commercial Distribution

  • 05690967584795 ()
PKN120017

  • Mechatronic external knee prosthesis
POWER KNEE G2 KIT NA EUP
OSSUR AMERICAS, INC.
PKN123007
Not in Commercial Distribution

  • 05690967566029 ()
PKN123007

  • Motorized external knee prosthesis
POWER KNEE BATTERY CHARGER NA
OSSUR AMERICAS, INC.
PK220007
Not in Commercial Distribution

  • 05690967556815 ()
PK220007

  • Motorized external knee prosthesis
POWER KNEE G2 KIT NA
OSSUR AMERICAS, INC.
PKN120007
Not in Commercial Distribution

  • 05690967529772 ()
PKN120007

  • Motorized external knee prosthesis
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0408
In Commercial Distribution

  • 00848665001655 ()


  • Screwing power tool attachment
PPS ANCILLARY PACK, FG PKG
Bayer Healthcare LLC
104834-002
In Commercial Distribution

  • 00616258005102 ()
  • 10616258005109 ()
104834

  • General-purpose catheter connector, sterile
No Description
Biomet Orthopedics, LLC
245014
In Commercial Distribution

  • 00880304288799 ()
245014

  • Orthopaedic implant-instrument extension adaptor, single-use
A device supplying power to the flat panel sensor and connecting between the flat panel sensor and the control cabinet.
FUJIFILM CORPORATION
DR-ID 1200 PB E
In Commercial Distribution

  • 04547410319385 ()


  • Diagnostic x-ray digital imaging conversion system
No Description
Chungwoo Co., Ltd.
SP-30H,IS-14
In Commercial Distribution

  • 08809495931293 ()


  • Electrical mains power cable
Diagnostic Ultrasound Accessory
FUJIFILM SONOSITE, INC.
P30826-01
In Commercial Distribution

  • 00841517108335 ()
P30826

  • General-purpose ultrasound imaging system
Accessory for Janus and Turbo
FUJIFILM SONOSITE, INC.
P30825-01
In Commercial Distribution

  • 00841517108328 ()
P30825

  • General-purpose ultrasound imaging system
No Description
FUJIFILM SONOSITE, INC.
P13559-06
In Commercial Distribution

  • 00841517105594 ()
P13559

  • General-purpose ultrasound imaging system
No Description
FUJIFILM SONOSITE, INC.
P12822-45
In Commercial Distribution

  • 00841517104641 ()
P12822

  • General-purpose ultrasound imaging system
No Description
FUJIFILM SONOSITE, INC.
P25003-15
In Commercial Distribution

  • 00841517106348 ()
P25003

  • General-purpose ultrasound imaging system
Power Supply - Pulse S. African Adapter
NORMATEC INDUSTRIES LP
Power Supply - Pulse S. African Adapter
In Commercial Distribution

  • 00817369020606 ()
30112

  • Intermittent venous compression system
  • Sequential venous compression system
Power Supply - Pulse US Adapter
NORMATEC INDUSTRIES LP
Power Supply - Pulse US Adapter
In Commercial Distribution

  • 00817369020590 ()
30111

  • Sequential venous compression system
  • Intermittent venous compression system
Power Supply - Pulse UK Adapter
NORMATEC INDUSTRIES LP
Power Supply - Pulse UK Adapter
In Commercial Distribution

  • 00817369020583 ()
30110

  • Intermittent venous compression system
  • Sequential venous compression system
Power Supply - Pulse EU Adapter
NORMATEC INDUSTRIES LP
Power Supply - Pulse EU Adapter
In Commercial Distribution

  • 00817369020576 ()
30109

  • Sequential venous compression system
  • Intermittent venous compression system
Power Supply - Pulse AU Adapter
NORMATEC INDUSTRIES LP
Power Supply - Pulse AU Adapter
In Commercial Distribution

  • 00817369020569 ()
30108

  • Intermittent venous compression system
  • Sequential venous compression system
Power Supply - 12 V DC 30 Watt
NORMATEC INDUSTRIES LP
Power Supply - 12V DC 30 Watt
In Commercial Distribution

  • 00817369020545 ()
30106

  • Intermittent venous compression system
  • Sequential venous compression system
Power Supply - 12 V DC 60 Watt
NORMATEC INDUSTRIES LP
Power Supply - 12V DC 60 Watt
In Commercial Distribution

  • 00817369020538 ()
30105

  • Sequential venous compression system
  • Intermittent venous compression system
MTO DYONICS POWER ITALIAN KIT
Smith & Nephew, Inc.
7205892
Not in Commercial Distribution

  • 03596010430908 ()
7205892

  • Surgical power tool system control unit, line-powered
MTO DYONICS POWER FRENCH KIT
Smith & Nephew, Inc.
7205889
Not in Commercial Distribution

  • 03596010411013 ()
7205889

  • Surgical power tool system control unit, line-powered
DYONICS POWER SAGITTAL SAW ATTACHMENT
Smith & Nephew, Inc.
7205791
In Commercial Distribution

  • 03596010410733 ()
7205791

  • Surgical power tool system handpiece, sawing, line-powered
DYONICS POWER KEYLESS CHUCK 1/8
Smith & Nephew, Inc.
7205793
In Commercial Distribution

  • 03596010409010 ()
7205793

  • Surgical drill chuck
MTO DYONICS POWER DUTCH KIT
Smith & Nephew, Inc.
7205891
Not in Commercial Distribution

  • 03596010420145 ()
7205891

  • Surgical power tool system control unit, line-powered
MTO DYONICS POWER GERMAN KIT
Smith & Nephew, Inc.
7205890
Not in Commercial Distribution

  • 03596010420138 ()
7205890

  • Surgical power tool system control unit, line-powered
DYONICS POWER INTL KIT 230-240V
Smith & Nephew, Inc.
7205888
In Commercial Distribution

  • 03596010420121 ()
7205888

  • Insufflation gas conditioning system control unit
DYONICS POWER KYLESS CHUCK 1/4
Smith & Nephew, Inc.
7205795
In Commercial Distribution

  • 03596010419507 ()
7205795

  • Surgical drill chuck
No Description
C.P. MEDICAL CORPORATION
CPF-P05A
In Commercial Distribution

  • 20790986004584 ()
  • 10790986004587 ()


  • Polyolefin/fluoropolymer suture, multifilament
No Description
C.P. MEDICAL CORPORATION
CPF-P026
In Commercial Distribution

  • 20790986004553 ()
  • 10790986004556 ()


  • Polyolefin/fluoropolymer suture, multifilament
No Description
C.P. MEDICAL CORPORATION
CPF-P02
In Commercial Distribution

  • 20790986004546 ()
  • 10790986004549 ()


  • Polyolefin/fluoropolymer suture, multifilament
General purpose ultrasonic cleaning solution
CETYLITE INDUSTRIES INC
0130
In Commercial Distribution

  • 10631059013016 ()

  • Total Volume: 32 Fluid Ounce
0130

  • Medical device cleaning agent
POWER TUBE - CLEAR 030DIA 50FT SPOOL
ORMCO CORPORATION
640-6031
In Commercial Distribution

  • 00889989056563 ()

  • Length: 50 Feet


  • Orthodontic archwire/bracket ligature
POWER TUBE - GRAY 030DIA 50FT SPOOL
ORMCO CORPORATION
640-6030
In Commercial Distribution

  • 00889989056556 ()

  • Length: 50 Feet


  • Orthodontic archwire/bracket ligature
POWER TUBE - CLEAR 025DIA 50FT SPOOL
ORMCO CORPORATION
640-6026
In Commercial Distribution

  • 00889989056549 ()

  • Length: 50 Feet


  • Orthodontic archwire/bracket ligature
POWER TUBE - GRAY 025DIA 50FT SPOOL
ORMCO CORPORATION
640-6025
In Commercial Distribution

  • 00889989056532 ()

  • Length: 50 Feet


  • Orthodontic archwire/bracket ligature
POWER TUBE 030 CLEAR 25FT PKG ASSY
ORMCO CORPORATION
640-4031
In Commercial Distribution

  • 00889989056525 ()

  • Length: 25 Feet


  • Orthodontic archwire/bracket ligature
POWER TUBE 030 GRAY 25FT PKG ASSY
ORMCO CORPORATION
640-4030
In Commercial Distribution

  • 00889989056518 ()

  • Length: 25 Feet


  • Orthodontic archwire/bracket ligature
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