iCAS-LV

FDA 510(k)

FDA Class 2 ·Radiology

GYMFORM ABS-A-ROUND

FDA 510(k)

FDA Class 2 ·Physical Medicine

Diode laser therapy device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GEMORE OTC TENS

FDA 510(k)

FDA Class 2 ·Neurology

Intense pulsed light therapy device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELECTROSURGICAL GENERATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheter, Peritoneal, Long-Term Indwelling, Exempt

FDA classification

FDA Class 2 ·Catheter, Peritoneal, Long-Term Indwelling, Exempt

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single Use Arthroscopic Electrode (with Pencil)

FDA 510(k)

FDA Class 2 ·Orthopedic

Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)

FDA 510(k)

FDA Class 2 ·Physical Medicine

CO2 Laser Machine (Lume)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Q-Switched Nd:Yag laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable General Electrode

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRO MARC LENSES (HYDROPHILIC)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS EUROPASS PTCA DILATATION CATHETER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·VISTAKON (ETAFILICON A) HYDROPHILIC CONTACT LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS PREDATOR PTCA DILITATION CATHETER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRO-MARC (ETALFILCON A) CONTACT LENES

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS PTCA DILATATION CATHETER