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for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622939-120
Not in Commercial Distribution
- 00802526623103 ()
2939
- Implantable cardiac device management application software
Babysat System Application.
Owlet Baby Care, Inc.
2.23.0
In Commercial Distribution
- 00810099090079 ()
- Multiple vital physiological parameter monitoring system, home-use
Mobile App utilized in the PDM (Personal Device Manager) for Dash Insulin pump secondary display. PDM Device 18239; app 41252
Insulet Corporation
1.3.1
In Commercial Distribution
- 10385081120265 ()
18239
- Ambulatory insulin infusion pump software, data-display
Hearing Implant Software for iOS Devices
COCHLEAR LIMITED
P1861019
In Commercial Distribution
- 09321502065764 ()
P2006651
- Audiometric/hearing device software
Hearing Implant Software for Android Devices
COCHLEAR LIMITED
P1860864
In Commercial Distribution
- 09321502065757 ()
P2006652
- Audiometric/hearing device software
Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-02-300
In Commercial Distribution
- 00817491023537 ()
FG-5502-02-300
- Implantable glucose monitoring system
Eversense Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend
information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-02-300
In Commercial Distribution
- 00817491023520 ()
FG-5501-02-300
- Implantable glucose monitoring system
Device Name: Curasan OSSEOLIVE® DENTAL
lndications for Use:
OSSEOLIVE® DENTAL is indicated for applications in oral and
maxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled
(artificial or degenerative) bone defects, e.g.:
- Defects after the extirpation of bone cysts
- Augmentation of an atrophied alveolar ridge
- Sinus lift or sinus floor elevation (subantral augmentation)
- Filling of alveolar defects after tooth extraction for preservation of the alveolar ridge
- Filling of extraction defects to create an implant bed
- Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects
- Defects after operative removal of retained teeth or corrective osteotomies
curasan AG
250-1000µm
In Commercial Distribution
- ECURL20M0250 ()
- ECURL20M02505 ()
5x2.0 cc
- Dental bone matrix implant, synthetic
CC527 Multi-Level Carton
Rna Medical Division
CC527 Multi-Level
In Commercial Distribution
- 10851290002444 ()
CC 527
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
CC527 Level 3 carton
Rna Medical Division
CC527 Level 3
In Commercial Distribution
- 10851290002437 ()
CC 527-3
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
CC527 Level 2 Carton
Rna Medical Division
CC527 Level 2
In Commercial Distribution
- 10851290002420 ()
CC 527-2
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
CC527 Level 1 Carton
Rna Medical Division
CC527 Level 1
In Commercial Distribution
- 10851290002413 ()
CC 527-1
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Hygieia d-Nav System Phone App - Android Operating System
HYGIEIA, INC.
V1m00b053d
In Commercial Distribution
- 00860001044218 ()
- Calculator, programmable
Irregular Rhythm Notification feature iPhone App (Version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution
- 00194252456781 ()
- Self-care monitoring/reporting software
Irregular Rhythm Notification feature Watch App (Version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution
- 00194252456774 ()
- Self-care monitoring/reporting software
DreamMapper Mobile App Android, EMEA Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution
- 00606959054233 ()
1128265
- Self-care monitoring/reporting software
Ovy by Beurer Basal Thermometer with Ovy App
BEURER NORTH AMERICA, L.P.
OT20
In Commercial Distribution
- 20850003500434 ()
- 10850003500437 ()
- 00850003500430 ()
790.70
- Thermometric fertility analyser
ASSURE patient app is a component of CareStation.
Kestra Medical Technologies, Inc.
80429-003
80429-003
- Medical equipment clinical data interfacing software
ASSURE patient app is a component of CareStation.
Kestra Medical Technologies, Inc.
80601-001
80601-001
- Medical equipment clinical data interfacing software
DS Panacea APP Adj Pump & Deluxe Single Pad
COMPASS HEALTH BRANDS CORP.
DS-APP1-SYS
In Commercial Distribution
- 30092237623825 ()
- 00092237623824 ()
- Alternating-pressure bed mattress overlay system
Lathbury cotton app 6" serr tip l/m
Medicon eG. Chirurgiemechaniker-Genossenschaft
955.62.60
In Commercial Distribution
- 04046826203382 ()
955.62.60
- Surgical tamp, reusable
WIRE SPEC TEMP APP NASAL SD 2 INCHES
SKLAR CORPORATION
22-8824
In Commercial Distribution
- 10649111346149 ()
- Eyelid speculum, reusable
SW APP A72400 SCS CLINICIAN PP NG RC
MEDTRONIC, INC.
A72400
In Commercial Distribution
- 00763000371470 ()
- Multiple active implantable device programmer
SW APP A71400 SCS CLINICIAN CP NG RC
MEDTRONIC, INC.
A71400
In Commercial Distribution
- 00763000371463 ()
- Multiple active implantable device programmer
SW APP A72200 SCS PATIENT NG PAIN PC
MEDTRONIC, INC.
A72200
In Commercial Distribution
- 00763000287290 ()
- Multiple active implantable device programmer
SW APP A51200 GU CLINICIAN MICRO EU MDR
MEDTRONIC, INC.
A51200
In Commercial Distribution
- 00763000970062 ()
- Multiple active implantable device programmer
SW APP A52200 GU PATIENT MICRO EU MDR
MEDTRONIC, INC.
A52200
In Commercial Distribution
- 00763000970079 ()
- Multiple active implantable device programmer
SW APP A820 TDD PATIENT PROG V2.X
MEDTRONIC, INC.
A820
In Commercial Distribution
- 00763000632793 ()
- Infusion pump programmer
SW APP A810 TDD CLINICIAN PROG V2.X
MEDTRONIC, INC.
A810
In Commercial Distribution
- 00763000632786 ()
- Infusion pump programmer
SW APP A71200 SCS CLINICIAN NG PAIN PC
MEDTRONIC, INC.
A71200
In Commercial Distribution
- 00763000520083 ()
- Multiple active implantable device programmer
Diatro•Hypoclean CC hypochlorite cleaning concentrate is a stabilized and micro-filtered concentrated hypochlorite solution for intensive oxidative cleaning, rinsing and washing of hematology analyzers’ capillaries, tubing and chambers, removing blood component precipitates and lipoprotein deposits on all hematology analyzers.
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
D801
In Commercial Distribution
- 15999883586638 ()
- 05999883586631 ()
- Total Volume: 100 Milliliter
D8011
- Wash/cleaning solution IVD, automated/semi-automated system
Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB2508SX
In Commercial Distribution
- 00813909013206 ()
- 8.0cc
NB2508SX
- Bone matrix implant, synthetic, non-antimicrobial
No Description
I3 IMPLANT LLC
i3CCAA
In Commercial Distribution
- 00850008541803 ()
- Dental implant suprastructure, temporary, preformed, reusable
No Description
I3 IMPLANT LLC
i3CCSA
In Commercial Distribution
- 00850008541797 ()
- Dental implant suprastructure, temporary, preformed, reusable
OsteoBoost is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, OsteoBoost resorbs and is later replaced by natural bone. It provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.
OsteoBoost is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.
The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
OB-10P
In Commercial Distribution
- 00816125023400 ()
OB-10P
- Bone matrix implant, synthetic, non-antimicrobial
OsteoBoost is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, OsteoBoost resorbs and is later replaced by natural bone. It provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.
OsteoBoost is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.
The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
OB-05P
In Commercial Distribution
- 00816125023394 ()
OB-05P
- Bone matrix implant, synthetic, non-antimicrobial
Compactor
SpineArt SA
TRY-IN 01 00-N
In Commercial Distribution
- 07640151081881 ()
TRY-IN 01 00-N
- Bone graft packing block
Convex Trial D14 H12
SpineArt SA
TRY-IA 14 12-N
In Commercial Distribution
- 07640151081836 ()
TRY-IA 14 12-N
- Surgical implant/trial-implant/sizer holder, reusable
Convex Trial D14 H11
SpineArt SA
TRY-IA 14 11-N
In Commercial Distribution
- 07640151081829 ()
TRY-IA 14 11-N
- Surgical implant/trial-implant/sizer holder, reusable
Convex Trial D14 H10
SpineArt SA
TRY-IA 14 10-N
In Commercial Distribution
- 07640151081812 ()
TRY-IA 14 10-N
- Surgical implant/trial-implant/sizer holder, reusable