FDA Pre-Market Approval

NIR ELITE MONORAIL AND OVER-THE-WIRE(OTW) STENT SYSTEMS

BAUMER CEMENTED HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

BAUMER FEMORAL HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

BAUMER LOCKING NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

BAUMER MULLER HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

Atlas Surgical and Prosthetic Instrumentation Kit

FDA UDI

Dentatus AB·07350081494872·ATLAS Surgical and Prosthetic Instrumentation k...

Ophthalmic Surgical Microscope: EOM 1

FDA registration

EYEVIS MEDIWORKS PRIVATE LIMITED·1 product·🇮🇳 India

Auto Lensmeter: ELM 1

FDA registration

EYEVIS MEDIWORKS PRIVATE LIMITED·1 product·🇮🇳 India

Auto Perimeter: EP 1

FDA registration

EYEVIS MEDIWORKS PRIVATE LIMITED·1 product·🇮🇳 India

Auto refkeratometer: RM KR 9900, ERK 1F

FDA registration

EYEVIS MEDIWORKS PRIVATE LIMITED·1 product·🇮🇳 India

Corneal Topographer: ECT 1

FDA registration

EYEVIS MEDIWORKS PRIVATE LIMITED·1 product·🇮🇳 India

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS2 CORONARY STENT SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS2 CORONARY STENT SYSTEM

CRAIGWELL AID HA300

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

3nethra neo

FDA 510(k)

FDA Class 2 ·Ophthalmic

CRAIGWELL AID FITTING SYSTEM AFS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CRAIGWELL MASTER HEARING AID MHA

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Dural Sealant System

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL EXACT SPINE SEALANT SYSTEM