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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Hourigan H5
Zoll-Dental
ELE-H5
In Commercial Distribution

  • 00840105203438 ()


  • Dental elevator, tooth/root
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
MasterScreen IOS
Jaeger Medical GmbH
V-176420
In Commercial Distribution

  • 04250892905631 ()
V-176420

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176450-13
In Commercial Distribution

  • 04250892905242 ()
176450-13

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420
Not in Commercial Distribution

  • 04250892900469 ()
V-176420

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420-03
Not in Commercial Distribution

  • 04250892900445 ()
V-176420-03

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-376406
In Commercial Distribution

  • 04250892905808 ()
V-376406

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420-13
In Commercial Distribution

  • 04250892905259 ()
V-176420-13

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176400
In Commercial Distribution

  • 04250892905235 ()
176400

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176400
Not in Commercial Distribution

  • 04250892902777 ()
176400

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420-03
Not in Commercial Distribution

  • 04250892902760 ()
V-176420-03

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176400-03
Not in Commercial Distribution

  • 04250892902746 ()
V-176400-03

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420-13
Not in Commercial Distribution

  • 04250892900513 ()
V-176420-13

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176450-13
Not in Commercial Distribution

  • 04250892900476 ()
176450-13

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176400
Not in Commercial Distribution

  • 04250892900452 ()
176400

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176400-03
Not in Commercial Distribution

  • 04250892900438 ()
V-176400-03

  • Pulmonary function analysis system, adult
RMDpulse (iOS)
RESMED CORP.
22253
In Commercial Distribution

  • 00840193400030 ()


  • Ventilator application software
for iOS
COCHLEAR LIMITED
NSA-1 / v5
In Commercial Distribution

  • 09321502062206 ()
P1834114

  • Audiometric/hearing device software
for iOS
COCHLEAR LIMITED
NSA-1 / v4
In Commercial Distribution

  • 09321502060486 ()
P1787372

  • Audiometric/hearing device software
G6 iOS
Dexcom, Inc.
SW11677
In Commercial Distribution

  • 00386270000804 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025100 ()
MLL-EG30001

  • Radiology information system application software
No Description
Thought Technology Ltd.
SA4515
In Commercial Distribution

  • 07540191000630 ()


  • Psychophysiological biofeedback system
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
In Commercial Distribution

75750

  • Rectal irrigation system application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
Not in Commercial Distribution

  • 07392532242373 ()
75750

  • Rectal irrigation system application software
Eversense NOW Remote Monitoring mobile application (iOS) is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information.
SENSEONICS, INCORPORATED
FG-5901-01-300
In Commercial Distribution

  • 00817491021267 ()
FG-5901-01-300

  • Implantable glucose monitoring system
SH5/H56 H5/H5 SCAL #6 HDL 1P
Peter Brasseler Holdings, LLC
5023409U0
In Commercial Distribution

  • 00887919682066 ()


  • Manual dental scaler, reusable
Extra Large Back Table Cover, 94 X 58, LML Barcode, Barrier 82X27
Lac-Mac Limited
025ZS
In Commercial Distribution

  • 00627755250667 ()

  • Height: 58 Inch
  • Width: 94 Inch
025ZS

  • Patient surgical drape, reusable
#H5 SE Scaler
HU-FRIEDY MFG. CO., LLC
SH5
In Commercial Distribution

  • 10889950095864 ()


  • Manual dental scaler, reusable
H5, Langer 6
HU-FRIEDY MFG. CO., LLC
SC7056
In Commercial Distribution

  • 10889950094171 ()


  • Periodontal curette
ORTHODONTIC, H5/BANDPUSHER
Power Dental U.S.A. Inc.
5876
In Commercial Distribution

  • D94358760 ()
5876

  • Dental spatula, reusable
  • Dental amalgam carrier
  • Orthodontic metal band pusher
H5/Gracey-Uni 1
Zoll-Dental
S-H5/GRAUNI1
In Commercial Distribution

  • 00840105213604 ()


  • Manual dental scaler, reusable
SCALERS H5/30
Power Dental U.S.A. Inc.
1237
In Commercial Distribution

  • D94312370 ()
1237

  • Dental excavator, reusable
  • Manual dental scaler, reusable
SCALERS H5/L5
Power Dental U.S.A. Inc.
1235
In Commercial Distribution

  • D94312350 ()
1235

  • Dental excavator, reusable
  • Manual dental scaler, reusable
SCALERS H5/N48
Power Dental U.S.A. Inc.
1233
In Commercial Distribution

  • D94312330 ()
1233

  • Dental excavator, reusable
  • Manual dental scaler, reusable
SCALERS H5/5
Power Dental U.S.A. Inc.
1229
In Commercial Distribution

  • D94312290 ()
1229

  • Dental excavator, reusable
  • Manual dental scaler, reusable
SCALER #H5/33
J & J INSTRUMENTS INC
11-533
In Commercial Distribution

  • 00817524024234 ()


  • Manual dental scaler, reusable
Scaler H5/N48
Surgical Direct, Inc.
SD1233
In Commercial Distribution

  • B382SD12330 ()
SD1233

  • Dental elevator, tooth/root
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