PERIMETRICS PERIOMETER

FDA 510(k)

FDA Class 1 ·Dental

BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEARFLASH AC2100 COSMETIC SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

PF1 Delivery System W/DCD

FDA UDI

Candela Corporation·00817495021225·Delivery System Assembly

Soles Neoprene Malleolus Ankle Brace Breathable Neoprene, Extreme Comfort - One Size Fits All - Fits Both Feet - Soft, Flexible, Comfortable - Reduces Pain and Prevents Injuries - Stabilizes Ankle

Device

EU MDR · Eu Md Class 1 ·Tuna Dis Tic. Ve Paz. Ltd. Sti·On the market

Soles Neoprene Ankle Brace Breathable Neoprene, Extreme Comfort - One Size Fits All - Fits Both Feet - Soft, Flexible, Comfortable - Reduces Pain and Prevents Injuries - Stabilizes Ankle

Device

EU MDR · Eu Md Class 1 ·Tuna Dis Tic. Ve Paz. Ltd. Sti·On the market

Soles Metatarsal Pad, Lightweight, Unisex, One Size Silicone Self-Stick Foot Cushions - Realign Toes & Prevents Inter-Digital Toe Abrasion - Washable & Reusable,Transparent

Device

EU MDR · Eu Md Class 1 ·Tuna Dis Tic. Ve Paz. Ltd. Sti·On the market

Soles One Size Silicone Bunione Protector

Device

EU MDR · Eu Md Class 1 ·Tuna Dis Tic. Ve Paz. Ltd. Sti·On the market

Soles Thumb Stabilizer Brace (SLS507)

Device

EU MDR · Eu Md Class 1 ·Tuna Dis Tic. Ve Paz. Ltd. Sti·On the market

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

FDA Pre-Market Approval

FDA Class 3 ·LCS(R) TOTAL KNEE SYSTEM DESIGN MODIFICATION TO ROTATING PLATFORM BEARINGS

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

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM - PFC SIGMA RPF KNEE SYSTEM

DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D

FDA 510(k)

FDA Class 2 ·Ophthalmic

SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

NOVEL PRINT CYAN ALGINATES

FDA 510(k)

FDA Class 2 ·Dental

ID MILLENNIUM, ID MOMENTS SILICONE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FEMMYCYCLE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FITPACK

FDA 510(k)

FDA Class 2 ·General Hospital