98 results · 36ms · Sources: EU EUDAMED, US FDA

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Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·LIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control HCV Ab

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·LIAISON XL MUREX HCV Ab

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·LIAISON XL MUREX HCV Ab

Phasix

FDA UDI
Davol Inc.·00801741107511·Phasix Mesh, 4.5" (11 cm), Circle

SOL-M 1ml Slip Tip Syringe w/o Needle

FDA UDI
Sol-Millennium Medical, Inc.·00810018097523·

Fecal Containment Device

FDA UDI
C. R. Bard, Inc.·00801741050930·FCD Fecal Containment Device

OsteoMed

FDA UDI
OSTEOMED LLC·00845694089432·11mm, OsteoFlap

OsteoMed

FDA UDI
OSTEOMED LLC·00845694005500·11mm, OsteoFlap, Sterile

Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)

FDA 510(k)
FDA Class 2 ·Cardiovascular

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·Puregraft Serene Breast Implant

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM

TREO ABDOMINAL STENT-GRAFT SYSTEM

FDA Adverse Event
Malfunction ·BOLTON MEDICAL, INC.·Product code MIH·July 12, 2022

TREO ABDOMINAL STENT-GRAFT SYSTEM

FDA Adverse Event
Injury ·BOLTON MEDICAL, INC.·Product code MIH·February 16, 2021

TREO ABDOMINAL STENT-GRAFT SYSTEM

FDA Adverse Event
Injury ·BOLTON MEDICAL, INC.·Product code MIH·May 4, 2022

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·IDEAL IMPLANT® Structured Breast Implant

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·Ideal Implant Saline-filled Breast Implant

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·IDEAL IMPLANT Structured Breast Implant

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM