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Instrument Tray Base
KICO KNEE INNOVATION COMPANY PTY LIMITED
10900
In Commercial Distribution
- 00850012315001 ()
- Instrument tray, reusable
No Description
STERILUCENT, INC.
HC 80TT-120-001
In Commercial Distribution
- 00850012210009 ()
HC 80TT-120-001
- Hydrogen peroxide gas sterilizer
BioPoly® Great Toe Hemiarthroplasty Implant - 20mm Porous
Biopoly, LLC
135-5120
In Commercial Distribution
- 00850012119418 ()
- Outer Diameter: 20 Millimeter
135-5120
- Partial metatarsophalangeal joint prosthesis
BioPoly® Great Toe Hemiarthroplasty Implant - 18mm Porous
Biopoly, LLC
135-5118
In Commercial Distribution
- 00850012119401 ()
- Outer Diameter: 18 Millimeter
135-5118
- Partial metatarsophalangeal joint prosthesis
BioPoly® Great Toe Hemiarthroplasty Implant - 16mm Porous
Biopoly, LLC
135-5116
In Commercial Distribution
- 00850012119395 ()
- Outer Diameter: 16 Millimeter
135-5116
- Partial metatarsophalangeal joint prosthesis
BioPoly® Great Toe Hemiarthroplasty Implant - 14mm Porous
Biopoly, LLC
135-5114
In Commercial Distribution
- 00850012119388 ()
- Outer Diameter: 14 Millimeter
135-5114
- Partial metatarsophalangeal joint prosthesis
The Unite Medical® heel stabilizer is designed with medical grade silicone combined with a soft gel center providing pain relief to the heel region. The heel stabilizer helps to reduce pain associated with Achilles tendinitis, plantar fasciitis, heel and calcaneal spurs as well as providing additional load & vibration relief for arthritis in the knee and leg joints.
Unite Medical, LLC
Heel Stabilizer (XLarge)
In Commercial Distribution
- 00850012035640 ()
HS3170-XL
- Heel stirrup cushion/pad, reusable
The Unite Medical® heel stabilizer is designed with medical grade silicone combined with a soft gel center providing pain relief to the heel region. The heel stabilizer helps to reduce pain associated with Achilles tendinitis, plantar fasciitis, heel and calcaneal spurs as well as providing additional load & vibration relief for arthritis in the knee and leg joints.
Unite Medical, LLC
Heel Stabilizer (Large)
In Commercial Distribution
- 00850012035633 ()
HS3170-L
- Heel stirrup cushion/pad, reusable
The Unite Medical® heel stabilizer is designed with medical grade silicone combined with a soft gel center providing pain relief to the heel region. The heel stabilizer helps to reduce pain associated with Achilles tendinitis, plantar fasciitis, heel and calcaneal spurs as well as providing additional load & vibration relief for arthritis in the knee and leg joints.
Unite Medical, LLC
Heel Stabilizer (Medium)
In Commercial Distribution
- 00850012035626 ()
HS3170-M
- Heel stirrup cushion/pad, reusable
The Unite Medical® heel stabilizer is designed with medical grade silicone combined with a soft gel center providing pain relief to the heel region. The heel stabilizer helps to reduce pain associated with Achilles tendinitis, plantar fasciitis, heel and calcaneal spurs as well as providing additional load & vibration relief for arthritis in the knee and leg joints.
Unite Medical, LLC
Heel Stabilizer (Small)
In Commercial Distribution
- 00850012035619 ()
HS3170-S
- Heel stirrup cushion/pad, reusable
The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Right, XLarge)
In Commercial Distribution
- 00850012035442 ()
KO4552R-XL
- Knee support orthosis
The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Right, Large)
In Commercial Distribution
- 00850012035428 ()
KO4552R-L
- Knee support orthosis
The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Right, Medium)
In Commercial Distribution
- 00850012035411 ()
KO4552R-M
- Knee support orthosis
The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Left, XLarge)
In Commercial Distribution
- 00850012035404 ()
KO4552L-XL
- Knee support orthosis
The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Left, Large)
In Commercial Distribution
- 00850012035398 ()
KO4552L-L
- Knee support orthosis
The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Left, Medium)
In Commercial Distribution
- 00850012035381 ()
KO4552L-M
- Knee support orthosis
The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Right, Small)
In Commercial Distribution
- 00850012035374 ()
KO4552R-S
- Knee support orthosis
The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Left,Small)
In Commercial Distribution
- 00850012035367 ()
KO4552L-S
- Knee support orthosis
The Unite Medical® single upright knee orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A single lateral upright design in conjunction with flex-hinge to unload the medial compartment of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Single Upright Knee Orthosis (Right, Universal)
In Commercial Distribution
- 00850012035251 ()
KO4351R
- Knee support orthosis
The Unite Medical® single upright knee orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A single lateral upright design in conjunction with flex-hinge to unload the medial compartment of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Single Upright Knee Orthosis (Left, Universal)
In Commercial Distribution
- 00850012035244 ()
KO4351L
- Knee support orthosis
The Unite Medical® Deluxe Universal ROM Knee Brace is indicated for mild to moderate ligament joint pain, sprains, and strains of the knee ligaments. This lightweight brace design connects the needs of the serious athlete with the added benefit of Range of Motion (ROM). Removable hinges allow for easy adjustment.
Unite Medical, LLC
Deluxe Universal ROM Knee Brace
In Commercial Distribution
- 00850012035138 ()
KO3233-1
- Knee support orthosis
The Unite Medical® Universal ROM Knee Brace is indicated for mild to moderate ligament joint pain, sprains, and strains of the knee ligaments. This lightweight brace design connects the needs of the serious athlete with the added benefit of Range of Motion (ROM). Removable hinges allow for easy adjustment.
Unite Medical, LLC
Universal ROM Knee Brace
In Commercial Distribution
- 00850012035121 ()
KO3233
- Knee support orthosis
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7103106-100
In Commercial Distribution
- 10850011833831 ()
- 00850011833834 ()
- 80850011833830 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8033106-100
In Commercial Distribution
- 10850011833824 ()
- 00850011833827 ()
- 80850011833823 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8103108-100
In Commercial Distribution
- 10850011833794 ()
- 00850011833797 ()
- 80850011833793 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8102912-100
In Commercial Distribution
- 10850011833787 ()
- 00850011833780 ()
- 80850011833786 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8053108-100
In Commercial Distribution
- 10850011833770 ()
- 00850011833773 ()
- 80850011833779 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8052912-100
In Commercial Distribution
- 10850011833763 ()
- 00850011833766 ()
- 80850011833762 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8033108-100
In Commercial Distribution
- 10850011833756 ()
- 00850011833759 ()
- 80850011833755 ()
- Insulin syringe/needle, basic
The Canary Home Base Station (Bluetooth) subsystem is a unit with embedded firmware that facilitate communication with CTE and CSE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient.
Canary Medical USA LLC
43-5570-001-15
In Commercial Distribution
- 00850015699153 ()
- Medical networking interface unit
Hermes TyPEEK Curve Cage 13mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-T2813023-S
In Commercial Distribution
- 00850015638893 ()
HRM-T2813023-S
- Metal-polymer composite spinal interbody fusion cage
Hermes TyPEEK Curve Cage 12mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-T2812023-S
In Commercial Distribution
- 00850015638886 ()
HRM-T2812023-S
- Metal-polymer composite spinal interbody fusion cage
Hermes TyPEEK Curve Cage 11mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-T2811023-S
In Commercial Distribution
- 00850015638879 ()
HRM-T2811023-S
- Metal-polymer composite spinal interbody fusion cage
Hermes TyPEEK Curve Cage 10mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-T2810023-S
In Commercial Distribution
- 00850015638862 ()
HRM-T2810023-S
- Metal-polymer composite spinal interbody fusion cage
Hermes TyPEEK Curve Cage 8mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-T288023-S
In Commercial Distribution
- 00850015638848 ()
HRM-T288023-S
- Metal-polymer composite spinal interbody fusion cage
Hermes TyPEEK Straight Cage 11mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-P2811012-S
In Commercial Distribution
- 00850015638817 ()
HRM-P2811012-S
- Metal-polymer composite spinal interbody fusion cage
Hermes TyPEEK Straight Cage 10mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-P2810012-S
In Commercial Distribution
- 00850015638800 ()
HRM-P2810012-S
- Metal-polymer composite spinal interbody fusion cage
Hermes TyPEEK Straight Cage 8mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-P288012-S
In Commercial Distribution
- 00850015638787 ()
HRM-P288012-S
- Metal-polymer composite spinal interbody fusion cage
Hermes TyPEEK Straight Cage 13mmx24mmx10mm, 0°
Tyber Medical LLC
HRM-P2413010-S
In Commercial Distribution
- 00850015638770 ()
HRM-P2413010-S
- Metal-polymer composite spinal interbody fusion cage
Hermes TyPEEK Straight Cage 12mmx24mmx10mm, 0°
Tyber Medical LLC
HRM-P2412010-S
In Commercial Distribution
- 00850015638763 ()
HRM-P2412010-S
- Metal-polymer composite spinal interbody fusion cage