55 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Material, Dressing, Surgical, Polylactic Acid
FDA Pre-Market Approval
FDA Class 3
·COLLACOTE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM
Device, Dermal Replacement
FDA Pre-Market Approval
FDA Class 3
·INTEGRA DERMAL REGENERATION TEMPLATE
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT FREE PSA ASSAY
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ARCHITECT TOTAL PSA ASSAY
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS-MICROFIBRILLAR FORM, COLLASTAT ABSORABLE COLAGEN HEMOSTATIC SPONGE
Material, Dressing, Surgical, Polylactic Acid
FDA Pre-Market Approval
FDA Class 3
·COLLACOTE,COLLATAPE,COLLAPLUG ABSORABLE COLLAGEN WOUND DRESS
Device, Dermal Replacement
FDA Pre-Market Approval
FDA Class 3
·INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
FDA Pre-Market Approval
FDA Class 3
·remede® System
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 2000+ LOW INTENSITY FRACTURE HEALING SYSTEM
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 4000+BONE HEALING SYSTEM
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 2000+
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 3000
Cap, Cervical, Contraceptive
FDA Pre-Market Approval
FDA Class 3
·PRENTIF TM CAVITY RIM CERVICAL CAP
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN ULTRASOUND BONE HEALING SYSTEM