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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Calcium compound bone void filler with DBM (3 cc), previously sold under Trabexus® EB brand name.
Vivorte, Inc
3 cc
In Commercial Distribution

  • W4146EB0003T0475 ()
130703-03

  • Cadaveric-donor/synthetic mineral bone graft
No Description
PARKS MEDICAL ELECTRONICS, INC.
812-1-901 CC
In Commercial Distribution

  • 00816787020427 ()


  • Laser Doppler blood flowmeter
No Description
PARKS MEDICAL ELECTRONICS, INC.
812-1-800 CC
In Commercial Distribution

  • 00816787020410 ()


  • Laser Doppler blood flowmeter
No Description
TEKNIMED
11 CC
Not in Commercial Distribution

  • 03760177046344 ()
183901000

  • Vertebral bone filler, non-bioabsorbable
No Description
TEKNIMED
11 CC
Not in Commercial Distribution

  • 03760177043947 ()
183901000

  • Vertebral bone filler, non-bioabsorbable
MICRO ARTERY CLAMP DOUBLE WITH FRAME ADJUSTABLE, TYPE 3, 1.0 - 2.2 MM LENGTH 16 MM
Gimmi GmbH
CC.1162.10
In Commercial Distribution

  • 04049047694984 ()
CC.1162.10

  • Surgical A/V-shaped microvessel clamp
MICRO ARTERY CLAMP DOUBLE ADJUSTABLE, TYPE 2, 0.6 - 1.4 MM LENGTH 11 MM
Gimmi GmbH
CC.1160.06
In Commercial Distribution

  • 04049047694878 ()
CC.1160.06

  • Surgical A/V-shaped microvessel clamp
MICRO ARTERY CLAMP SINGLE TYPE 5, 2.0 - 5.0 MM LENGTH 36 MM
Gimmi GmbH
CC.1158.20
In Commercial Distribution

  • 04049047694809 ()
CC.1158.20

  • Surgical A/V-shaped microvessel clamp
MICRO ARTERY CLAMP SINGLE TYPE 4, 1.5 - 3.3 MM LENGTH 24 MM
Gimmi GmbH
CC.1158.15
In Commercial Distribution

  • 04049047694793 ()
CC.1158.15

  • Surgical A/V-shaped microvessel clamp
MICRO ARTERY CLAMP SINGLE TYPE 2, 0.6 - 1.4 MM LENGTH 11 MM
Gimmi GmbH
CC.1158.06
In Commercial Distribution

  • 04049047694779 ()
CC.1158.06

  • Surgical A/V-shaped microvessel clamp
OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked.
DATUM DENTAL LTD
0.250 cc
In Commercial Distribution

  • 07290015477222 ()

  • Height: 5 Millimeter
  • Length: 10 Millimeter
  • Depth: 5 Millimeter
  • 0.250 cc
OXB0250

  • Dental bone matrix implant, synthetic
OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked.
DATUM DENTAL LTD
0.125 cc
In Commercial Distribution

  • 07290015477215 ()

  • 0.125 cc
  • Depth: 5 Millimeter
  • Length: 5 Millimeter
  • Height: 5 Millimeter
OXB0125

  • Dental bone matrix implant, synthetic
OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling and cell-mediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 2.5 cc, 5 cc and 10 cc sizes. (510(k) no. K193075)
Ossdsign AB
1 cc
In Commercial Distribution

  • 07350086550733 ()
104010

  • Bone matrix implant, synthetic, non-antimicrobial
CommunicationConsole is part of NordicNeuroLab’s Audio System. The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. The Communication Console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone.
Nordicneurolab AS
CC 2.3
In Commercial Distribution

  • 07090042053044 ()


  • Auditory stimulator
Corplex P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
4 cc
In Commercial Distribution

  • 00860471002572 ()
CP-0040

  • Animal-derived wound matrix dressing
Corplex P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
2 cc
In Commercial Distribution

  • 00860471002565 ()
CP0020

  • Animal-derived wound matrix dressing
Corplex P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
1 cc
In Commercial Distribution

  • 00860471002558 ()
CP-0010

  • Animal-derived wound matrix dressing
Allacor P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
4 cc
In Commercial Distribution

  • 00850039927362 ()
AP-0040

  • Animal-derived wound matrix dressing
Allacor P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
2 cc
In Commercial Distribution

  • 00850039927355 ()
AP-0020

  • Animal-derived wound matrix dressing
Allacor P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
1 cc
In Commercial Distribution

  • 00850039927348 ()
AP-0010

  • Animal-derived wound matrix dressing
OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked.
DATUM DENTAL LTD
0.500 cc
In Commercial Distribution

  • 07290015477253 ()

  • Height: 5 Millimeter
  • Length: 10 Millimeter
  • Depth: 10 Millimeter
  • 0.500 cc
OXB0500

  • 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
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
Hygieia d-Nav System Phone App - Android Operating System
HYGIEIA, INC.
V1m00b053d
In Commercial Distribution

  • 00860001044218 ()


  • Calculator, programmable
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
WIRE SPEC TEMP APP NASAL SD 2 INCHES
SKLAR CORPORATION
22-8824
In Commercial Distribution

  • 10649111346149 ()


  • Eyelid speculum, reusable
ASSURE patient app is a component of CareStation.
Kestra Medical Technologies, Inc.
80601-001
In Commercial Distribution

80601-001

  • Medical equipment clinical data interfacing software
ASSURE patient app is a component of CareStation.
Kestra Medical Technologies, Inc.
80429-003
In Commercial Distribution

80429-003

  • 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
Irregular Rhythm Notification feature Watch App (Version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00194252456774 ()


  • Self-care monitoring/reporting software
Irregular Rhythm Notification feature iPhone App (Version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00194252456781 ()


  • Self-care monitoring/reporting software
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
SW APP A72200 SCS PATIENT NG PAIN PC
MEDTRONIC, INC.
A72200
In Commercial Distribution

  • 00763000287290 ()


  • Multiple active implantable device programmer
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 A71200 SCS CLINICIAN NG PAIN PC
MEDTRONIC, INC.
A71200
In Commercial Distribution

  • 00763000520083 ()


  • 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 A51200 GU CLINICIAN MICRO EU MDR
MEDTRONIC, INC.
A51200
In Commercial Distribution

  • 00763000970062 ()


  • 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
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
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
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