Placental Alpha Microglobulin-1 Immunoassay

FDA Pre-Market Approval

FDA Class 3 ·PartoSure Test

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA Pre-Market Approval

FDA Class 3 ·AvertD and AvertD Buccal Sample Collection Kit

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD, S VR ICD, XT DR ICD, XT VR ICD; INTRINSIC ICD; MARQUIS DR ICD, VR ICD; MAXIMO DR ICD, MAXIMO II ICD, MAX

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Max

INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

REVELATION STEM, MODEL 427-21/42-080/180

FDA 510(k)

FDA Class 3 ·Orthopedic

1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS

FDA 510(k)

FDA Class 3 ·Unknown

MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 483-02 PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFELINE ENDOCARDIAL BIPOLAR LEAD 484-03

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY

FDA 510(k)

FDA Class 3 ·Cardiovascular

INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 366-09 ADAPTAID ADAPTER SLEEVE

FDA 510(k)

FDA Class 3 ·Cardiovascular

POLYFLEX IMPLANTABLE PACING LEAD-476-07

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFELINE ENDOCARDIAL BIPOLAR LEAD 476-06

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 430-07 ENDOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

SUPRIMA MODEL 254-24

FDA 510(k)

FDA Class 3 ·Cardiovascular