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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25ga Stellaris Elite Vitrectomy Probe
SYNERGETICS USA, INC.
SE5625
In Commercial Distribution

  • 20841305111442 ()
  • 10841305111438 ()
SE5625

  • Hereditary cerebral haemorrhage with amyloidosis (Dutch type) IVD, kit, nucleic acid technique (NAT)
23ga Stellaris Elite Vitrectomy Probe
SYNERGETICS USA, INC.
SE5623
In Commercial Distribution

  • 20841305111428 ()
  • 10841305111414 ()
SE5623

  • Hereditary cerebral haemorrhage with amyloidosis (Dutch type) IVD, kit, nucleic acid technique (NAT)
AR-8500HSO COOLCUT HOODLESS SHEATH (WHI
MEDLINE INDUSTRIES, INC.
REP111699
In Commercial Distribution

  • 10888277354616 ()

  • Outer Diameter: 5 Millimeter
REP111699

  • Arthroscopic shaver system blade, reprocessed
375-535-000 FRML TOMCAT CTR YELLOW/WHI
MEDLINE INDUSTRIES, INC.
375535000R
In Commercial Distribution

  • 20888277385211 ()
  • 10888277385214 ()
375535000R

  • Arthroscopic shaver system blade, reprocessed
014723 @GORE SMOOTHER, CRUCIAL TOOL (WHI
MEDLINE INDUSTRIES, INC.
014723RH
In Commercial Distribution

  • 10888277384019 ()
014723RH

  • Bone file/rasp, reciprocating, single-use
DBD-BANDAGE,ELASTIC,SURE-WRAP,2"X5YD,WHI
MEDLINE INDUSTRIES, INC.
MDS057002G
In Commercial Distribution

  • 30080196300161 ()
  • 10080196575978 ()
MDS057002G

  • Pressure bandage, non-latex, single-use
014724 @GORE SMOOTHER, CRUCIAL TOOL (WHI
MEDLINE INDUSTRIES, INC.
014724RH
In Commercial Distribution

  • 10080196385485 ()
014724RH

  • Bone file/rasp, reciprocating, single-use
DRSG CHG KIT W-HI HUMIDITY DRS
MEDLINE INDUSTRIES, INC.
DYNDC3218
In Commercial Distribution

  • 40195327115655 ()
  • 10195327115654 ()
DYNDC3218

  • General surgical procedure kit, non-medicated, single-use
DRSG CHG KIT W-HI HUMIDITY DRS
MEDLINE INDUSTRIES, INC.
DYNDC3218A
In Commercial Distribution

  • 40198459313098 ()
  • 10198459313097 ()
DYNDC3218A

  • General surgical procedure kit, non-medicated, single-use
DBD-BANDAGE,ELASTIC,SURE-WRAP,6"X5YD,WHI
MEDLINE INDUSTRIES, INC.
MDS057006G
In Commercial Distribution

  • 40080196576068 ()
  • 30080196576061 ()
  • 10080196576067 ()
MDS057006G

  • Pressure bandage, non-latex, single-use
3010-PL VENAFLOW CALF CUFF,W/FOAM WHI
MEDLINE INDUSTRIES, INC.
3010PLR
In Commercial Distribution

  • 20888277386782 ()
  • 10888277386785 ()
  • 80888277386784 ()
3010PLR

  • Multi-chamber venous compression system garment, reprocessed
5898 @SCD EXPRESS FOOT CUFF, (1EA), (WHI
MEDLINE INDUSTRIES, INC.
UM5898CR
In Commercial Distribution

  • 10888277385627 ()

  • Circumference: 29 Inch
UM5898CR

  • Single-chamber venous compression system garment, reprocessed
5897 @SCD EXPRESS FOOT CUFF, (1EA), (WHI
MEDLINE INDUSTRIES, INC.
UM5897CR
In Commercial Distribution

  • 10888277385061 ()

  • Circumference: 29 Inch
UM5897CR

  • Single-chamber venous compression system garment, reprocessed
This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
Shenzhen Konmed Technology Co., Ltd.
KM531
In Commercial Distribution

  • 06970935830543 ()


  • Pelvic floor exercise biofeedback device
This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
Shenzhen Konmed Technology Co., Ltd.
KM530
In Commercial Distribution

  • 06970935830536 ()


  • Pelvic floor exercise biofeedback device
Also covers the following minor/medium updates: v3.1.0: (01)00860001471731(11)210526(10)310; v3.1.1 (01)00860001471731(11)210604(10)311; v3.1.2 (01)00860001471731(11)210625(10)312; v3.2.0 (01)00860001471731(11)210713(10)320; v3.2.1. (01)00860001471731(11)210804(10)321; v3.2.2 (01)00860001471731(11)210917(10)322; v3.2.3 (01)00860001471731(11)211026(10)323 ;v3.2.4 (01)00860001471731(11)211123(10)324; v3.4.0: (01)00860001471731(11)220609(10)340; v3.5.1 (01)00860001471731(11)220718(10)351; v3.6.0 (01)00860001471731(11)220926(10)360; v3.6.2(01)00860001471731(11)221024(10)362; v3.7.0(01)00860001471731(11)221116(10)370; v3.8.0(01)00860001471731(11)221215(10)380; v3.8.1(01)00860001471731(11)230127(10)381; v3.9.0(01)00860001471731(11)230217(10)390; v3.9.1(01)00860001471731(11)230417(10)391; v3.9.2 (01)00860001471731(11)230609(10)392; v3.9.3 (01)00860001471731(11)230714(10)393; v3.10.0 (01)00860001471731(11)231013(10)3100
AMPLIFON SPA
Android v3
In Commercial Distribution

  • 00860001471731 ()


  • Hearing aid/implant system remote control
Also covers the following minor/medium updates: v3.1.0 (01)00860001471724(11)210526(10)310; v3.1.1 (01)00860001471724(11)210604(10)311; v3.1.2 (01)00860001471724(11)210625(10)312; v3.2.0 (01)00860001471724(11)210713(10)320; v3.2.1. (01)00860001471724(11)210804(10)321; v3.2.2 (01)00860001471724(11)210917(10)322; v3.2.3 (01)00860001471724(11)211026(10)323 ;v3.2.4 (01)00860001471724(11)211123(10)324; v3.7.0 (01)00860001471724(11) 221116(10)370; v3.6.2 (01)00860001471724(11) 221024(10)362; v3.4.0:(01)00860001471724(11)220609(10)350; v3.5.1(01)00860001471724(11)220718(10)351; v3.6.0 (01)00860001471724(11) 220926(10)360; v3.8.0 (01)00860001471724(11) 221215(10)380; v3.8.1 (01)00860001471724(11) 230127(10)381; v3.9.0 (01)00860001471724(11) 230217(10)390; v3.9.1 (01)00860001471724(11) 230417(10)391; v3.9.2 (01)00860001471724(11) 230609(10)392; v3.9.3 (01)00860001471724(11) 230714(10)393; v3.10.0 (01)00860001471724(11) 231013(10)3100
AMPLIFON SPA
iOS v3
In Commercial Distribution

  • 00860001471724 ()


  • Hearing aid/implant system remote control
App Android 2.0.1. This database entry also covers the following minor/medium software updates: v2.0.2: (01)00860001471717(11)190807(10)202; v2.0.3: (01)00860001471717(11)190927(10)203; v2.0.4: (01)00860001471717(11)191014(10)204; v2.0.5: (01)00860001471717(11)191218(10)205; v2.0.6: (01)00860001471717(11)200227(10)206; v2.1.0: (01)00860001471717(11)200420(10)210; v2.2.1: (01)00860001471717(11)200729(10)221; v2.3.0: (01)00860001471717(11)201217(10)230; v2.3.1: (01)00860001471717(11)210205(10)231; v2.3.2: (01)00860001471717(11)210507(10)232
AMPLIFON SPA
2.0.1
In Commercial Distribution

  • 00860001471717 ()


  • Hearing aid/implant system remote control
App IOS 2.0.1. This database entry also covers the following minor/medium software updates: v2.0.2: (01)00860001471700(11)190807(10)202; v2.0.3: (01)00860001471700(11)190927(10)203; v2.0.4: (01)00860001471700(11)191014(10)204; v2.0.5: (01)00860001471700(11)191218(10)205; v2.0.6:(01)00860001471700(11)200227(10)206; v2.1.0: (01)00860001471700(11)200528(10)210; v2.2.1: (01)00860001471700(11)200729(10)221; v2.3.0: (01)00860001471700(11)201217(10)230; v2.3.1: (01)00860001471700(11)210205(10)231; v2.3.2: (01)00860001471700(11)210507(10)232
AMPLIFON SPA
2.0.1
In Commercial Distribution

  • 00860001471700 ()


  • Hearing aid/implant system remote control
Assure paste is intended for use as light cure, hydrophilic bracket adhesive, therefore it can be applied to a dry or slightly contaminated surface. The smooth cohesive paste viscosity allows for easy application to any style bracket base insuring maximum mechanical retention.
RELIANCE ORTHODONTIC PRODUCTS INC
APP
In Commercial Distribution

  • D798APP0 ()
APP

  • Orthodontic bracket adhesive
No Description
OXOS Medical, Inc.
APP
In Commercial Distribution

  • 00860008892744 ()


  • Hand-held basic diagnostic x-ray system, digital
SW APP 9735762 STEALTH S8 APP
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00643169865341 ()


  • Multi-purpose stereotactic surgery system
40 sticks of 26 ties. Used in orthodontics to hold arch wire to brackets. White color
PRACTICON, INC.
7163110 WHI
In Commercial Distribution

  • 00723896024294 ()
7163110 WHI

  • Orthodontic inter-arch elastic band
Rechargable electric toothbrush with high density bristles. 1 Sonic handle, 2 brush heads, and charging base and cable. White color
PRACTICON, INC.
7155010 WHI
In Commercial Distribution

  • 00723896018736 ()
  • 00723896018729 ()
7155010 WHI

  • Ionic electric toothbrush
high quality standards of traditional ejectors-onlyl! Unremovable clear ends
PRACTICON, INC.
70-19112 WHI
In Commercial Distribution

  • 00723896009574 ()
  • 00723896009567 ()
  • 00723896001264 ()
70-19112 WHI

  • Dental suction system cannula, single-use
APP REXTON
Ws Audiology Usa, Inc.
Rexton App
In Commercial Distribution

  • 05714880113204 ()
10996567

  • Hearing aid/implant system remote control
APP AUDIOSERVICE
Ws Audiology Usa, Inc.
AudioService App
In Commercial Distribution

  • 05714880113198 ()
10996566

  • Hearing aid/implant system remote control
APP MYREMOTE
Ws Audiology Usa, Inc.
myRemote App
In Commercial Distribution

  • 05714880113181 ()
10996565

  • Hearing aid/implant system remote control
APP VIBE
Ws Audiology Usa, Inc.
Vibe App
In Commercial Distribution

  • 05714880113174 ()
10996564

  • Hearing aid/implant system remote control
APP SIGNIA
Ws Audiology Usa, Inc.
Signia App
In Commercial Distribution

  • 05714880113167 ()
10996563

  • Hearing aid/implant system remote control
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