BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX

FDA 510(k)

FDA Class 2 ·Microbiology

Plasmodium Spp. Detection Reagents

FDA classification

FDA Class 2 ·Plasmodium Spp. Detection Reagents

BIP-COAX-SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URIC ACID (AOX), SCAL, NORTROL, ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3

FDA 510(k)

FDA Class 2 ·Radiology

OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTAL IMPLANT, WITH HEALING SCREW

FDA 510(k)

FDA Class 2 ·Dental

OPTI-MAX BODY DIAMETER W/5MM TOP W/EXTERNAL HEX, EXTERNALLY THREADED DENTAL IMPLANT COARSE THREADS

FDA 510(k)

FDA Class 2 ·Dental

OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25 DEGREE INCLINATIONS. FOR IMPLANTS 3.3MM, 4

FDA 510(k)

FDA Class 2 ·Dental

OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW

FDA 510(k)

FDA Class 2 ·Dental

OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL

FDA 510(k)

FDA Class 2 ·Dental

OPTI-MAX INTERNAL-HEX ANGLED IMPLANT CROWN POST, 10 DEGREE & 20 DEGREE INCLINATIONS

FDA 510(k)

FDA Class 2 ·Dental

PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SmartDrive Wheelchair Power Assist

FDA 510(k)

FDA Class 2 ·Physical Medicine

MAX I

FDA 510(k)

FDA Class 2 ·Cardiovascular

PDS Barbed Suture, PDO MAXX Threads

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SMARTDRIVE WHEELCHAIR POWER-ASSIST

FDA 510(k)

FDA Class 2 ·Physical Medicine

PDO Max Suture with Dual Needle

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

FDA 510(k)

FDA Class 2 ·Radiology