Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM - ADDITION OF POSTERIOR STABILIZED FEMORAL AND BEARING COMPONENTS & RPII TIBIAL TRAYS & BEARING CO

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IOLAB BRAND UVBLOC PLUS(LC) UV-ABSORBING PMMA PC IOL'S

Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

FDA classification

FDA Class 1 ·Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Aligner, Bracket, Orthodontic

FDA classification

FDA Class 1 ·Aligner, Bracket, Orthodontic

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·EASYCLEAN/GP, LC-65, LENS CLEAR, AND LENS PLUS, DAILY CLEANERS

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PREPSTAIN INSTRUMENT

SC MEDISERV SRL

Importer

🇷🇴 Romania·3 Manufacturers

Television Or Monitor, Non-Crt, Non-Medical, Video Display

FDA classification

FDA Not Classified ·Television Or Monitor, Non-Crt, Non-Medical, Video Display

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IOLAB BRAND MODEL 2192 KELMAN UVBLOC PLUS (LC) UV-ABSORBING PMMA AC IOLS

Orthana GmbH

Importer

🇩🇪 Germany·12 Manufacturers

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IOLAB BRAND MODEL U85J UVBLOC PLUS (LC) UV-ABSORBING ONE-PIECE FLEXIBLE AC IOLS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CROSS FLEX LC BALLOON-EXPANDABLE STENT WITH OVER THE WIRE DELIVERY SYSTEM FOR CORONARY ARTERIES

Momentum LC

Authorized representative

🇫🇷 France

Defib Deutschland GmbH

Importer

🇩🇪 Germany·1 Manufacturer

LHL, Landsforeningen for hjerte og lungesyke

Importer

🇳🇴 Norway·1 Manufacturer

Medizon B.V.

Importer

🇳🇱 Netherlands·1 Manufacturer

LABORATOIRE DE CONTACTOLOGIE APPLIQUEE - LCA

System producer

🇫🇷 France

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM