Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense E3 CGM System

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

CULLUM SINUS FLOOR ELEV 6 X 3 HF S/E

FDA UDI

W.H. Holden, Inc.·D928105953630·

CULLUM SINUS FLOOR ELEV 6 X 2 HF S/E

FDA UDI

W.H. Holden, Inc.·D928105953620·

CULLUM SINUS FLOOR ELEV 8 X 2 HF S/E

FDA UDI

W.H. Holden, Inc.·D928105953820·

CULLUM SINUS FLOOR ELEV 10 x 2 HF S/E

FDA UDI

W.H. Holden, Inc.·D92810595320·

CULLUM SINUS FLOOR ELEV 8 X 3 HF S/E

FDA UDI

W.H. Holden, Inc.·D928105953830·

CULLUM SINUS FLOOR ELEV 10 x 3 HF S/E

FDA UDI

W.H. Holden, Inc.·D92810595330·

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ILESTO/IFORIA 5/7 VRT/DRT ICD'S, ILESTO/IFORIA 5/7 HF-T CRT-D

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD

PANTHER Cutter Stapler

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SURGICRAFT COPELAND DISPOSABLE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic