DoubleChek DC-1001

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40

FDA 510(k)

FDA Class 2 ·Radiology

PEAK FLOWMETERS FOR SPIROMETRY

FDA 510(k)

FDA Class 2 ·Anesthesiology

UNI-TENS XL TENS

FDA 510(k)

FDA Class 2 ·Neurology

AGAR 9K TENS

FDA 510(k)

FDA Class 2 ·Neurology

UNI-TENS

FDA 510(k)

FDA Class 2 ·Neurology

InstaRISPACS / InstaZFP / InstaMobi v5.0

FDA 510(k)

FDA Class 2 ·Radiology

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABLSORBABLE SEALANT

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor

FDA 510(k)

FDA Class 2 ·Radiology

LAPAROSCOPIC ELECTROSURGICAL CANNULA W/RETRACTABLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELITE IBF

FDA 510(k)

FDA Class 2 ·Orthopedic

DISTENDABLE PALPATION PROBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INTRODE INT-8

FDA 510(k)

FDA Class 2 ·Neurology

STERILE SURGICAL DRAPES AND SHEETS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12

FDA 510(k)

FDA Class 2 ·Hematology