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VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE

FDA 510(k)
FDA Class 1 ·Dental

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

A.C.T. III

FDA 510(k)
FDA Class 1 ·Microbiology

XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B

FDA 510(k)
FDA Class 1 ·Microbiology

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

FDA 510(k)
FDA Class 2 ·Orthopedic

BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE

FDA 510(k)
FDA Class 1 ·Dental

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