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)
CONCISE ONE-PIECE LPW LG
DEROYAL INDUSTRIES, INC.
SL8001-37
In Commercial Distribution

  • 00749756077583 ()
SL8001-37

  • Ankle/foot orthosis
CONCISE ONE-PIECE LPW MD
DEROYAL INDUSTRIES, INC.
SL8001-35
In Commercial Distribution

  • 00749756077576 ()
SL8001-35

  • Ankle/foot orthosis
CONCISE ONE-PIECE LPW SM
DEROYAL INDUSTRIES, INC.
SL8001-33
In Commercial Distribution

  • 00749756077569 ()
SL8001-33

  • Ankle/foot orthosis
Oxalate Kit
TRINITY BIOTECH PUBLIC LIMITED COMPANY
591-D
In Commercial Distribution

  • 05391516742245 ()

  • 100 Tests
591-D

  • Oxalate IVD, kit, spectrophotometry
Oxalate Kit
TRINITY BIOTECH PUBLIC LIMITED COMPANY
591-C
In Commercial Distribution

  • 05391516742238 ()

  • 20 Tests
591-C

  • Oxalate IVD, kit, spectrophotometry
Oxalate Sample Diluent
TRINITY BIOTECH PUBLIC LIMITED COMPANY
591-4
In Commercial Distribution

  • 05391516742221 ()

  • Total Volume: 100 Milliliter
591-4

  • Oxalate IVD, reagent
Oxalate Standards 0.50 MMOL/L
TRINITY BIOTECH PUBLIC LIMITED COMPANY
591-3
In Commercial Distribution

  • 05391516742214 ()

  • Total Volume: 25 Milliliter
591-3

  • Oxalate IVD, calibrator
Sample Purifier Tubes
TRINITY BIOTECH PUBLIC LIMITED COMPANY
591-20
In Commercial Distribution

  • 05391516742207 ()
  • 05391516749602 ()

  • 20 Tubes
591-20

  • Oxalate IVD, reagent
Oxalate Reagent B
TRINITY BIOTECH PUBLIC LIMITED COMPANY
591-2
In Commercial Distribution

  • 05391516742191 ()

  • Total Volume: 2 Milliliter
591-2

  • Oxalate IVD, reagent
Oxalate Standards
TRINITY BIOTECH PUBLIC LIMITED COMPANY
591-11
In Commercial Distribution

  • 05391516742184 ()

  • 6 x 25 mL
591-11

  • Oxalate IVD, calibrator
Sample Purifier Tubes
TRINITY BIOTECH PUBLIC LIMITED COMPANY
591-100
In Commercial Distribution

  • 05391516742177 ()
  • 05391516749619 ()

  • 100 Tubes
591-100

  • Oxalate IVD, reagent
Oxalate Reagent A
TRINITY BIOTECH PUBLIC LIMITED COMPANY
591-10
In Commercial Distribution

  • 05391516742160 ()

  • Total Volume: 10 Milliliter
591-10

  • Oxalate IVD, reagent
Oxalate Sample Diluent
TRINITY BIOTECH PUBLIC LIMITED COMPANY
591-4-1000
In Commercial Distribution

  • 05391516749640 ()

  • Total Volume: 1000 Milliliter
591-4-1000

  • Oxalate IVD, reagent
IBP interface cable/华南医电/Edwards/LP5/4.0M
Unimed Medical Supplies, Inc.
BC-HY-ED
In Commercial Distribution

  • 06945664869171 ()


  • Electrical-only medical device connection cable, reusable
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
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