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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Angled Abutment Screw (1.25mm/.050"hex drive)
AMERICAN DENTAL IMPLANT CORPORATION
AS-A
In Commercial Distribution

  • D896ASA0 ()
AS-A

  • Dental prosthesis/implant abutment screw
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)
ANEROID SPHYGMOMANOMETER WITH SPRAGUE RAPPAPORT STETHOSCOPE
Wenzhou Caretek Medical Device Co., Ltd.
AS-MC-SR-KIT
In Commercial Distribution

  • 06975871430390 ()


  • Aneroid manual sphygmomanometer
ANEROID SPHYGMOMANOMETER
Wenzhou Caretek Medical Device Co., Ltd.
AS-MC
In Commercial Distribution

  • 06975871430383 ()


  • Aneroid manual sphygmomanometer
KELLY KIT ASA
MEDLINE INDUSTRIES, INC.
DYKM2157C
In Commercial Distribution

  • 40195327599035 ()
  • 10195327599034 ()
DYKM2157C

  • General surgical procedure kit, non-medicated, single-use
KELLY KIT ASA
MEDLINE INDUSTRIES, INC.
DYKM2157B
In Commercial Distribution

  • 40195327496464 ()
  • 10195327496463 ()
DYKM2157B

  • General surgical procedure kit, non-medicated, single-use
KELLY KIT ASA
MEDLINE INDUSTRIES, INC.
DYKM2157
In Commercial Distribution

  • 40195327138746 ()
  • 10195327138745 ()
DYKM2157

  • General surgical procedure kit, non-medicated, single-use
KELLY KIT ASA
MEDLINE INDUSTRIES, INC.
DYKM2157A
In Commercial Distribution

  • 40195327309474 ()
  • 10195327309473 ()
DYKM2157A

  • General surgical procedure kit, non-medicated, single-use
JEFF KIT ASA
MEDLINE INDUSTRIES, INC.
DYKM1947A
In Commercial Distribution

  • 40195327277964 ()
  • 10195327277963 ()
DYKM1947A

  • General surgical procedure kit, non-medicated, single-use
JEFF KIT ASA
MEDLINE INDUSTRIES, INC.
DYKM1947
In Commercial Distribution

  • 40193489337274 ()
  • 10193489337273 ()
DYKM1947

  • General surgical procedure kit, non-medicated, single-use
THORPE MAIN KIT ASA
MEDLINE INDUSTRIES, INC.
DYKM1946A
In Commercial Distribution

  • 40195327277957 ()
  • 10195327277956 ()
DYKM1946A

  • General surgical procedure kit, non-medicated, single-use
THORPE MAIN KIT ASA
MEDLINE INDUSTRIES, INC.
DYKM1946
In Commercial Distribution

  • 10193489337266 ()
  • 40193489337267 ()
DYKM1946

  • General surgical procedure kit, non-medicated, single-use
Reverse Lip ASA 32x180mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6211
In Commercial Distribution

  • 00841536137644 ()


  • Surgical retraction system, reusable
Reverse Lip ASA 32x170mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6210
In Commercial Distribution

  • 00841536137637 ()


  • Surgical retraction system, reusable
Reverse Lip ASA 32x160mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6209
In Commercial Distribution

  • 00841536137620 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Rigid-25x175mm
THOMPSON SURGICAL INSTRUMENTS, INC.
5518
In Commercial Distribution

  • 00841536134704 ()


  • Surgical retraction system, 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
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
Reusable SpO2 Sensor/超思/Soft Tip/Adult/3.0M/LP6
Unimed Medical Supplies, Inc.
U410S-96
In Commercial Distribution

  • 06945664821155 ()


  • Pulse oximeter probe, reusable
Reusable SpO2 Sensor/超思/Finger clip/Adult/3.0M/LP6
Unimed Medical Supplies, Inc.
U410B-96
In Commercial Distribution

  • 06945664821162 ()


  • Pulse oximeter probe, reusable
Sleep ASA - Preformed Tooth Positioner
ALLESEE AOA-PRO
3000-0131
In Commercial Distribution

  • 00889989075069 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Reverse Lip ASA Tapered 32x175mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6067
In Commercial Distribution

  • 00841536136166 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Tapered 25x175mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6066
In Commercial Distribution

  • 00841536136159 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Rigid 32x175mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6065
In Commercial Distribution

  • 00841536136142 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Rigid 25x70mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6062
In Commercial Distribution

  • 00841536136128 ()


  • Surgical retraction system, reusable
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