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ClearFit VDI Standard
LONGEVITI NEURO SOLUTIONS LLC
171716
In Commercial Distribution
- 00860003416303 ()
- Cranial resinous compound
Canturio® Smart Extension 14mm (D) x 30mm (H) with Canary Health Implanted Reporting Processor (CHIRP®) system is a tibial extension implant containing electronics
and software.
Canary Medical USA LLC
43-5570-030-14
In Commercial Distribution
- 00860003118399 ()
- Knee femur stem prosthesis
The canturio te (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized during by the physician during the course of patient monitoring and treatment post-surgery. The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58mm sized tibial stem extension. The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit. The CTE with CHIRP System is compatible with Zimmer Persona Personalized Knee System.
Canary Medical USA LLC
43-5570-058-14
In Commercial Distribution
- 00860003118306 ()
- Knee femur stem prosthesis
AbsorbaleGelatin Sponge
Orca Products, LLC
Standard
Not in Commercial Distribution
- 10860003109912 ()
- 00860003109915 ()
- 00860003109922 ()
- Gelatin haemostatic agent
Resorbable implant for anterior cruciate ligament (ACL) repair. A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.
Miach Orthopaedics, Inc.
1000
In Commercial Distribution
- 00860002987804 ()
- Joint cartilage biomatrix implant
No Description
EMBOLIC ACCELERATION, LLC
PEP-002-US
In Commercial Distribution
- 00860002787114 ()
- Non-neurovascular embolization plug, metallic
No Description
EMBOLIC ACCELERATION, LLC
PEP-001-US
In Commercial Distribution
- 00860002787107 ()
- Non-neurovascular embolization plug, metallic
PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (5 ml)
3-D MATRIX INC.
651-006
In Commercial Distribution
- 00860001820898 ()
651-006
- Synthetic peptide haemostatic agent
PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (1 mL)
3-D MATRIX INC.
651-007
In Commercial Distribution
- 00860001820843 ()
651-007
- Intranasal splint, biodegradable
PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (3 mL)
3-D MATRIX INC.
651-008
In Commercial Distribution
- 00860001820836 ()
- Intranasal splint, biodegradable