MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1

FDA 510(k)

FDA Class 2 ·Radiology

REVISED LABELING FOR NYLON SUTURE (POLYAMIDE)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMTEC BIOBARRIER MEMBRANE

FDA 510(k)

FDA Class 2 ·Dental

DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

RICH-MAR RM 2002 ULTRASOUND PHYSICAL THERAPY DEVIC

FDA 510(k)

FDA Class 2 ·Physical Medicine

MODIFICATION TO: WINNER ST-2 STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

RICH-MAR IF 200

FDA 510(k)

FDA Class 2 ·Physical Medicine

TransLoc 3D

FDA 510(k)

FDA Class 2 ·Orthopedic

VT-1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CRAG LATERAL FLOW ASSAY (CRAG LFA)

FDA 510(k)

FDA Class 2 ·Microbiology

Orchid Safety Release Valve(TM)

FDA 510(k)

FDA Class 2 ·General Hospital

HEXLOCK SCREW

FDA 510(k)

FDA Class 2 ·Dental

POWER TRAINER WITH NEUROMUSCULAR STIMULATION

FDA 510(k)

FDA Class 2 ·Physical Medicine

T-Rex Standalone ALIF

FDA 510(k)

FDA Class 2 ·Orthopedic

MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED

FDA 510(k)

FDA Class 2 ·Physical Medicine

NEUROLUMEN PN-1000

FDA 510(k)

FDA Class 2 ·Physical Medicine

Tent, Oxygen, Electrically Powered

FDA classification

FDA Class 2 ·Tent, Oxygen, Electrically Powered

NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz

FDA 510(k)

FDA Class 2 ·Immunology