PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000

FDA 510(k)

FDA Class 2 ·Anesthesiology

INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS

FDA 510(k)

FDA Class 2 ·Neurology

LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150

FDA 510(k)

FDA Class 2 ·Dental

ARGISTAR 72 (HIGH GOLD PLATINUM SILVER ALLOY FOR BOTH LOW FUSING PORCELAIN AND CROWN AND BRIDGE APPLICATION

FDA 510(k)

FDA Class 2 ·Dental

SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75

FDA 510(k)

FDA Class 2 ·Orthopedic

DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Immunology

SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR

FDA 510(k)

FDA Class 2 ·Orthopedic

FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS WITH 30MM BALLOON LENGTH

AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Material, Impression

FDA classification

FDA Class 2 ·Material, Impression

Preamplifier, Battery-Powered, Ophthalmic

FDA classification

FDA Class 2 ·Preamplifier, Battery-Powered, Ophthalmic

Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx

FDA 510(k)

FDA Class 2 ·Physical Medicine

STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW

FDA 510(k)

FDA Class 2 ·Hematology

SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK

FDA 510(k)

FDA Class 2 ·Orthopedic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SPRINTER OVER-THE-WIRE (OTW) BALLOON DILATATION CATHETER (MULTIPLE MODEL NUMBERS FOR THE 1.5 MM TO 4.0 MM DIAMETERS)

ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01

FDA 510(k)

FDA Class 2 ·Clinical Chemistry