AAP CANNULATED SCREW 2.0

FDA 510(k)

FDA Class 2 ·Orthopedic

AAP LOQTEC(R) OLECRANON PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG

FDA 510(k)

FDA Class 2 ·Orthopedic

SmoothSkin Pure Switch (SSC1)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SmoothSkin Pure Adapt (SSG3)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SmoothSkin Pure Unplugged (SSB3)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ASAP MUITISCOPE

FDA 510(k)

FDA Class 2 ·Orthopedic

ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,

FDA 510(k)

FDA Class 2 ·Orthopedic

ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CERAMCO CROWNS AND BRIDGES

FDA 510(k)

FDA Class 2 ·Dental

WARD-CSS (v1.2.x)

FDA 510(k)

FDA Class 2 ·Cardiovascular

EmbedMed

FDA 510(k)

FDA Class 2 ·Dental

EmbedMed

FDA 510(k)

FDA Class 2 ·Orthopedic

IPACS MEDICAL IMAGE MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ClearGuard HD Antimicrobial Barrier Cap

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CLEARGUARD HD END CAP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·VIS-SOL STERILE PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ISOTONIC STERILE UNPRESERVED SALINE SOLUTION