BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Encevis

FDA 510(k)

FDA Class 2 ·Neurology

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)

FDA 510(k)

FDA Class 2 ·Orthopedic

Bonebridge

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

g.Nautilus PRO

FDA 510(k)

FDA Class 2 ·Neurology

eMurmur Heart AI

FDA 510(k)

FDA Class 2 ·Cardiovascular

Micromate™ Navi+

FDA 510(k)

FDA Class 2 ·Radiology

DIMERTEST LATEX

FDA 510(k)

FDA Class 2 ·Hematology

cortiQ PRO

FDA 510(k)

FDA Class 2 ·Neurology

Ceramill A-Temp

FDA 510(k)

FDA Class 2 ·Dental

Proxeo ULTRA (PB-510, PB-520 and PB-530)

FDA 510(k)

FDA Class 2 ·Dental

mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ECG-ELECTRODE(SWAROMED)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) SOLO(TM) BALL. DIL. CATH. W/PRO/PEL COAT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) FORCE(R) BALL. DIL. CATH. W/PRO/PEL COAT.

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) SPRINT(TM) BALL. DIL. CATH. W/PRO/PEL COAT

Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System

FDA 510(k)

FDA Class 2 ·Orthopedic

ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL

FDA 510(k)

FDA Class 2 ·Orthopedic

REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS

FDA 510(k)

FDA Class 2 ·Orthopedic