REHASTIM & REHAMOVE

FDA 510(k)

FDA Class 2 ·Neurology

REHASTIM 2, ERIGOPRO (FES)

FDA 510(k)

FDA Class 2 ·Neurology

DETRUSAN 500

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PUREFILL OXYGEN COMPRESSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS

FDA 510(k)

FDA Class 2 ·Neurology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·BREAST COMPANION SOFTWARE SYSTEM

POREX(TM) EAR PROSTHESIS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CANAL WALL PROSTHESIS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ePTFE-Coated Auricular Implant

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ATTIC DEFECT PLATE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)

FDA Class 2 ·Medical Genetics

Quantidex qPCR BCR-ABL IS Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

FDA 510(k)

FDA Class 2 ·Medical Genetics

BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

FDA 510(k)

FDA Class 2 ·Medical Genetics

MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

FDA 510(k)

FDA Class 2 ·Medical Genetics

TROJAN PASSION BERRY GEL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TROJAN CRYSTAL CLEAR LIQUID

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OTOMIMIX

FDA 510(k)

FDA Class 2 ·Dental