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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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Synergetics - 10841305111438

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)

Synergetics - 10841305111414

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)

Unimed - 06945664824972

SpO2 interface cable/安维生-Philips/3.0M/087
Unimed Medical Supplies, Inc.
U710-169
In Commercial Distribution

  • 06945664824972 ()


  • Electrical-only medical device connection cable, reusable

Unimed - 06945664824958

SpO2 interface cable/安维生-Nellcor/3.0M/103X
Unimed Medical Supplies, Inc.
U710-170
In Commercial Distribution

  • 06945664824958 ()


  • Electrical-only medical device connection cable, reusable

KONMED /Pelvifine - 06970935830543

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

KONMED /Pelvifine - 06970935830536

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

Miracle Ear App - 00860001471731

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

Miracle Ear App - 00860001471724

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

Miracle-Ear App - 00860001471717

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

Miracle-Ear App - 00860001471700

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

NA - 03700712420390

VPS COM UPGRADE
MAQUET SAS
ARD568407908
Not in Commercial Distribution

  • 03700712420390 ()


  • Operating room light

NA - 03700712400965

VPS 3 COM
MAQUET SAS
ARD568407906
Not in Commercial Distribution

  • 03700712400965 ()


  • Operating room light

NA - 03700712400941

VPS 2 COM
MAQUET SAS
ARD568407904
Not in Commercial Distribution

  • 03700712400941 ()


  • Operating room light

NA - 03700712400927

VPS 1 COM
MAQUET SAS
ARD568407902
Not in Commercial Distribution

  • 03700712400927 ()


  • Operating room light

Unimed - 06945664803991

Reusable SpO2 Sensor/龙美尔/Finger Clip/Adult/3.0M/111
Unimed Medical Supplies, Inc.
U410-64
In Commercial Distribution

  • 06945664803991 ()


  • Pulse oximeter probe, reusable

Assure - D798APP0

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

Unimed - 06945664821568

Reusable SpO2 Sensor/龙美尔/Finger clip/Adult/3.0M/111/ASMUTH
Unimed Medical Supplies, Inc.
AS98.062.28E
In Commercial Distribution

  • 06945664821568 ()


  • Pulse oximeter probe, reusable

INTENSA - M368IN587WDCOM1

RECL WIDE DROP-AMR COM
GF HEALTH PRODUCTS, INC.
IN587WDCOM
In Commercial Distribution

  • M368IN587WDCOM1 ()


  • Reclining chair

CHATTANOOGA - 00888912268547

KIT SG SHOULDER COM
DJO, LLC
20660
In Commercial Distribution

  • 00888912268547 ()


  • Continuous passive motion joint exerciser

Medline Industries, Inc. - 10193489990959

LHK-PARMA COM GEN HOSP
MEDLINE INDUSTRIES, INC.
651621415
In Commercial Distribution

  • 40193489990950 ()
  • 10193489990959 ()
651621415

  • General surgical procedure kit, non-medicated, single-use

NA - 03700712420413

VPS 2 COM U
MAQUET SAS
ARD568407916
Not in Commercial Distribution

  • 03700712420413 ()


  • Operating room light

NA - 03700712420406

VPS 1 COM U
MAQUET SAS
ARD568407915
Not in Commercial Distribution

  • 03700712420406 ()


  • Operating room light

NA - 03700712415815

VPS 2 COM ORT
MAQUET SAS
ARD568407928
Not in Commercial Distribution

  • 03700712415815 ()


  • Operating room light

NA - 03700712415808

VPS 1 COM ORT
MAQUET SAS
ARD568407927
Not in Commercial Distribution

  • 03700712415808 ()


  • Operating room light

NA - 03700712415792

VPS 3 COM ORT
MAQUET SAS
ARD568407929
Not in Commercial Distribution

  • 03700712415792 ()


  • Operating room light

Supremo Instrumentos - 07908854001606

Afastador Obwegeser com cabo
ANDRE GREGATE BRAGA INSTRUMENTOS LTDA
S0914C
In Commercial Distribution

  • 07908854001606 ()


  • Hand-held dental retractor

Supremo Instrumentos - 07908854001590

Afastador Langenback com cabo
ANDRE GREGATE BRAGA INSTRUMENTOS LTDA
S0921C
In Commercial Distribution

  • 07908854001590 ()


  • Hand-held dental retractor

Albahealth - 00073614776777

PULSTAR LOGIX INTERMITTENT COM
Albahealth, LLC
0LX500000000304
In Commercial Distribution

  • 50073614776772 ()
  • 00073614776777 ()


  • Multi-chamber venous compression system garment, single-use

Unimed - 06945664817660

SpO2 interface cable/安维生/3.0M/073/客户订做
Unimed Medical Supplies, Inc.
U710-172
In Commercial Distribution

  • 06945664817660 ()


  • Electrical-only medical device connection cable, reusable

TECOtherm - 04260647540314

No Description
Tec Com Medizintechnik GmbH
NEO
In Commercial Distribution

  • 04260647540314 ()
8289830

  • External circulating-fluid core temperature regulation system control unit, heating/cooling

TECOtherm Wrabbit - 04260647540239

The TECOtherm Wrabbit is designed as a disposable device to help prevent postnatal heat and water loss in premature and newborn infants.
Tec Com Medizintechnik GmbH
M
In Commercial Distribution

  • 04260647540260 ()
  • 04260647540239 ()


  • Infant heat shield

TECOtherm Wrabbit - 04260647540215

The TECOtherm Wrabbit is designed as a disposable device to help prevent postnatal heat and water loss in premature and newborn infants.
Tec Com Medizintechnik GmbH
S
In Commercial Distribution

  • 04260647540215 ()
  • 04260647540253 ()


  • Infant heat shield

TECOtherm Wrabbit - 04260647540123

The TECOtherm Wrabbit is designed as disposable device to help prevent postnatal heat and water loss in premature and newborn infants.
Tec Com Medizintechnik GmbH
L
In Commercial Distribution

  • 04260647540277 ()
  • 04260647540123 ()


  • Infant heat shield

TCmatt - 04260647540031

Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns and infants.
Tec Com Medizintechnik GmbH
NEOmulti
In Commercial Distribution

  • 04260647540031 ()
6426801

  • External circulating-fluid core temperature regulation system pad, reusable

TCmatt - 04260647540017

Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns and infants.
Tec Com Medizintechnik GmbH
NEOsingle
In Commercial Distribution

  • 04260647540017 ()
  • 04260647540116 ()
6427401

  • External circulating-fluid core temperature regulation system pad, single-use

MC2 App - 00860008892744

No Description
OXOS Medical, Inc.
APP
In Commercial Distribution

  • 00860008892744 ()


  • Hand-held basic diagnostic x-ray system, digital

Skater™ Biliary Drainage Catheter Non-Locking Non-Locking - 00886333006106

Skater™ Biliary Drainage Catheter Non-Locking Non-Locking with Radiopaque Band(12Fr x 40 cm)
ARGON MEDICAL DEVICES, INC.
12Fr x 40 cm
In Commercial Distribution

  • 20886333006100 ()
  • 00886333006106 ()

  • 12 F x 40 com
755212040

  • Biliary drain

CARDINAL HEALTH - 10887488564746

KIT, TOTAL KNEE, HILLSDALE COM
Cardinal Health 200, LLC
POW1TKHIM
In Commercial Distribution

  • 50887488564744 ()
  • 10887488564746 ()
POW1TKHIM

  • Orthopaedic surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10193489391145

PK CUST NEURO CABRINI COM
MEDLINE INDUSTRIES, INC.
DYNJ60585A
In Commercial Distribution

  • 40193489391146 ()
  • 10193489391145 ()
DYNJ60585A

  • General surgical procedure kit, non-medicated, single-use

NAMIC - 10193489075182

3,PORT,KIT,COM HOSP
MEDLINE INDUSTRIES, INC.
650311521
In Commercial Distribution

  • 10193489075182 ()
  • 20193489075189 ()
650311521

  • Angiography kit

CARDINAL HEALTH - 10888439513165

KIT,TOTAL KNEE, NORTHWEST COM
Cardinal Health 200, LLC
POCGTKNWM
In Commercial Distribution

  • 50888439513163 ()
  • 10888439513165 ()
POCGTKNWM

  • Orthopaedic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10887488551425

KIT,TOTAL KNEE, NORTHWEST COM
Cardinal Health 200, LLC
POCGTKNWL
In Commercial Distribution

  • 50887488551423 ()
  • 10887488551425 ()
POCGTKNWL

  • Orthopaedic surgical procedure kit, non-medicated, single-use

SpO2.COM® NRC-GE Patient Cable - 00843997001397

SpO2.COM NRC-GE Patient Cable
MASIMO CORPORATION
1854
In Commercial Distribution

  • 00843997001397 ()
1854

  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-395 Patient Cable - 00843997001366

SpO2.COM NRC-395 Patient Cable
MASIMO CORPORATION
1811
In Commercial Distribution

  • 00843997001366 ()
1811

  • Electrical-only medical device connection cable, reusable

Medline Industries, Inc. - 10193489986297

3 PORT KIT COM HOSP
MEDLINE INDUSTRIES, INC.
650311521
In Commercial Distribution

  • 40193489986298 ()
  • 10193489986297 ()
650311521

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10193489523652

PK CUST NEURO CABRINI COM
MEDLINE INDUSTRIES, INC.
DYNJ60585
In Commercial Distribution

  • 10193489523652 ()
DYNJ60585

  • General surgical procedure kit, non-medicated, single-use

Supremo Instrumentos - 07908854000890

Broca Coletora com Capa 7.0
ANDRE GREGATE BRAGA INSTRUMENTOS LTDA
S7923
In Commercial Distribution

  • 07908854000890 ()


  • Surgical screwdriver, reusable

NORDENT MANUFACTURING INC - 00840018636057

SPECIAL COM PLACM PER MICRODEN
NORDENT MANUFACTURING INC
PFICOMP14
In Commercial Distribution

  • 00840018636057 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635746

COM PLACEMENT INST DE WOODSN #
NORDENT MANUFACTURING INC
CEPFIW1
In Commercial Distribution

  • 00840018635746 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635548

COM PLACEMENT INST DE WOODSN #
NORDENT MANUFACTURING INC
REPFIW1
In Commercial Distribution

  • 00840018635548 ()


  • Margin finishing dental file/rasp, reusable
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