ORTHOFIBER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EOCD

FDA 510(k)

FDA Class 2 ·Anesthesiology

CAPINTEC MODEL 292 ELECTROMETER

FDA 510(k)

FDA Class 2 ·Radiology

Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CRC-15BT

FDA 510(k)

FDA Class 2 ·Radiology

SIS System (Version 5.6.0)

FDA 510(k)

FDA Class 2 ·Radiology

CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12

FDA 510(k)

FDA Class 2 ·Orthopedic

PLUS REUSABLE RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

RH-801, MODEL TRANSQ

FDA 510(k)

FDA Class 2 ·Physical Medicine

SIMPLASTIN L

FDA 510(k)

FDA Class 2 ·Hematology

SUTUREFIX Curved Suture Anchor

FDA 510(k)

FDA Class 2 ·Orthopedic

ECHELON GRAY CARTRIDGE, MODEL ERC45M

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPS 1550 SINGLE NEEDLE PATIENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO: ARTHREX INTERFERENCE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC

FDA 510(k)

FDA Class 2 ·Cardiovascular

SLENDERTONE FLEX MAX, MODEL 517 US

FDA 510(k)

FDA Class 2 ·Physical Medicine

MONO-SWIFT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

API UNISCEPT KB/TYPE 2 AND 3

FDA 510(k)

FDA Class 2 ·Microbiology