RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060

FDA 510(k)

FDA Class 2 ·Dental

ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125

FDA 510(k)

FDA Class 2 ·Radiology

FX WIRE ADVANCED MEASUREMENT GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODULAR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Epic Biliary Endoscopic Stent System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PREG-Q EARLY PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

injeTAK Adjustable Tip Needle (DIS199; DIS201)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CERAMIX PORCELAIN SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX

FDA 510(k)

FDA Class 2 ·Dental

SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WALLFLEX BILIARY RX STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER

FDA 510(k)

FDA Class 2 ·General Hospital

ORISE Gel

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

METALYZER, MODEL 2; METALYZER, MODEL 3

FDA 510(k)

FDA Class 2 ·Anesthesiology

EBI XFIX DFS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET

FDA 510(k)

FDA Class 2 ·General Hospital

NARKOMAT, MODEL 2000

FDA 510(k)

FDA Class 2 ·Anesthesiology