Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVELIGHT EX500 LASER SYSTEM, ALLEGRO ANALYZER

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF (GRAFTSKIN)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Simplicity Delivery System, SmartLOAD Delivery Technology, TECNIS iTec Preloaded Delivery System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVELIGHT EX 500 LASER SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM VOLUMA XC

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm® Volbella™ XC

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS

IV Pole (IVDMR506, IV-Pole, IV110,IV112,IVP-SA, IVP-SA-L),X-Ray Cassette Holder (CTKXCAS), Self Help Pole(SP001, SP002)

FDA registration

Caretek(China) Medical PLC·1 product·🇨🇳 China

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·cobas HPV Test, 240 Tests

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·OrganOx metra® System

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Blazer and IntellaNav/MiFi Open-Irrigated Ablation Catheters

Diagnostic Low Electric Field

FDA Pre-Market Approval

FDA Class 3 ·MarginProbe System

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·RxSight Light Adjustable Lens (LAL) and light Delivery Device (LDD)

E-PASS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Sientra Silicone Gel Breast Implants

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Audit MicroControls Linearity FD D-Dimer PATHFAST Immunoanalyzer

FDA UDI

AALTO SCIENTIFIC·B085K883M50·

HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI)

FDA UDI

INSIGHTEC LTD·07290019402466·HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI). M...

Audit MicroControls Linearity FD D-Dimer Siemens Stratus

FDA UDI

AALTO SCIENTIFIC·B085K893M50·

HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI)

FDA UDI

INSIGHTEC LTD·07290019402442·HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI). M...