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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
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
- Collagen 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
- Collagen 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
- Collagen wound matrix dressing
Micro Catheter System
TERUMO CLINICAL SUPPLY CO., LTD.
CC*M1916DN
In Commercial Distribution
- 54987350741023 ()
- 04987350741028 ()
- Length: 165 Centimeter
- Catheter Inner Diameter: 0.48 Millimeter
- Outer Diameter: 0.64 Millimeter
CCM1916DN
- Vascular microcatheter
Micro Catheter System
TERUMO CLINICAL SUPPLY CO., LTD.
CC*M1916AN
In Commercial Distribution
- 54987350741009 ()
- 04987350741004 ()
- Length: 165 Centimeter
- Catheter Inner Diameter: 0.48 Millimeter
- Outer Diameter: 0.64 Millimeter
CCM1916AN
- Vascular microcatheter
Micro Catheter System
TERUMO CLINICAL SUPPLY CO., LTD.
CC*M1916SN
In Commercial Distribution
- 04987350740984 ()
- 54987350740989 ()
- Length: 165 Centimeter
- Catheter Inner Diameter: 0.48 Millimeter
- Outer Diameter: 0.64 Millimeter
CCM1916SN
- Vascular microcatheter
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
- Collagen 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
- Collagen 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
- Collagen wound matrix dressing
Calcium compound bone void filler (10 cc)
Vivorte, Inc
10 cc
In Commercial Distribution
- 00868201000188 ()
- Bone matrix implant, synthetic, non-antimicrobial
Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
In Commercial Distribution
- 00868201000171 ()
131133-05-S
- Bone matrix implant, synthetic, non-antimicrobial
Calcium compound bone void filler (3 cc)
Vivorte, Inc
3 cc
In Commercial Distribution
- 00868201000164 ()
131133-03-S
- Bone matrix implant, synthetic, non-antimicrobial
Calcium compound bone void filler (10 cc)
Vivorte, Inc
10 cc
Not in Commercial Distribution
- 00868201000157 ()
- Bone matrix implant, synthetic, non-antimicrobial
Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
Not in Commercial Distribution
- 00868201000140 ()
- Bone matrix implant, synthetic, non-antimicrobial
Calcium Bone Void Filler (3 cc)
Vivorte, Inc
3 cc
Not in Commercial Distribution
- 00868201000133 ()
- Bone matrix implant, synthetic, non-antimicrobial
Calcium compound bone void filler (10 cc)
Vivorte, Inc
10 cc
Not in Commercial Distribution
- 00868201000126 ()
131133-10
- Bone matrix implant, synthetic, non-antimicrobial
Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
Not in Commercial Distribution
- 00868201000119 ()
131133-05
- Bone matrix implant, synthetic, non-antimicrobial
Calcium compound bone void filler (3cc)
Vivorte, Inc
3 cc
Not in Commercial Distribution
- 00868201000102 ()
131133-03
- Bone matrix implant, synthetic, non-antimicrobial
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 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
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
Bellafill 1.5ml on 1.5cc syringe
SUNEVA MEDICAL, INC.
1.5 cc
In Commercial Distribution
- 10350224000148 ()
- 00350224000141 ()
- 20350224000145 ()
- 30350224000142 ()
GBF0115, GBF0215, GBF0315
- Dermal tissue reconstructive material, animal-derived
Bellafill 0.8ml on 1.0cc syringe
SUNEVA MEDICAL, INC.
1.0 cc
In Commercial Distribution
- 00350224000028 ()
- 10350224000025 ()
- 20350224000022 ()
GBF0208, GBF0508
- Dermal tissue reconstructive material, animal-derived
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
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
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
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
For the wireless mode version of the subject device, to be used in combination with an application installed on a tablet, the SPM01K3 convenience kit includes:
1 electrostimulator SPM01M1 configuration;
electrodes;
protective skin, and
1 tablet with the MySPM mobile application (SPM01A1).
NCS LAB SRL
SPM01K3
In Commercial Distribution
- 08051122040964 ()
SPM01K3
- Physical therapy transcutaneous neuromuscular electrical stimulation system
Mobile App utilized in the PDM (Personal Device Manager) for Dash. Insulin pump secondary display. PDM Device 18239; app 41253
Insulet Corporation
1.3.1
In Commercial Distribution
- 10385081120272 ()
18239
- Ambulatory insulin infusion pump software, data-display
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
No Description
CURBELL MEDICAL PRODUCTS, INC.
Rego Safe Mobility App
In Commercial Distribution
- 00840828192095 ()
- Inpatient motion surveillance software
for iOS
COCHLEAR LIMITED
NSA-1 / v5
In Commercial Distribution
- 09321502062206 ()
P1834114
- Audiometric/hearing device software
for Android
COCHLEAR LIMITED
NSA-2 / v5
In Commercial Distribution
- 09321502062190 ()
P1834165
- Audiometric/hearing device software
for iOS
COCHLEAR LIMITED
NSA-1 / v4
In Commercial Distribution
- 09321502060486 ()
P1787372
- Audiometric/hearing device software
for Android
COCHLEAR LIMITED
NSA-2 / v4
In Commercial Distribution
- 09321502060479 ()
P1787373
- Audiometric/hearing device software
DreamMapper iOS EU Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution
- 00606959051348 ()
1128264
- Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution
- 00606959049949 ()
1128264
- Self-care monitoring/reporting software
DreamMapper iOS APAC Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution
- 00606959049109 ()
1127959
- Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution
- 00606959049093 ()
1128264
- Self-care monitoring/reporting software
DreamMapper iOS APAC Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution
- 00606959051355 ()
1127959
- Self-care monitoring/reporting software
DreamMapper iOS APAC Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution
- 00606959049956 ()
1127959
- Self-care monitoring/reporting software
The .decimal Astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments.
DECIMAL, INC.
1.0
In Commercial Distribution
- 00851147007076 ()
- Radiation therapy software
No Description
Boston Brace International, Inc.
SENSOR-MA-V1
In Commercial Distribution
- 00860013109813 ()
- Wireless patient monitor/sensor reporting software, layperson-use
No Description
NFANT LABS LLC
1
In Commercial Distribution
- 00861410000246 ()
NA4
- Biofeedback system application software
Eko mobile app for Android platforms for use with Eko products.
Eko Devices, Inc.
1.2.9
In Commercial Distribution
- 00863609000341 ()
- Medical equipment clinical data interfacing software
iOS mobile device software for use with Eko products.
Eko Devices, Inc.
3.1.1
In Commercial Distribution
- 00863609000334 ()
- Medical equipment clinical data interfacing software