System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·OMNISCEPT(TM) KB SYSTEM

V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

V.A.C. VERAFLO CLEANSE DRESSING SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

V.A.C.ULTA Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

V.A.C. THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)

FDA 510(k)

FDA Class 2 ·Radiology

MAF Guard

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

V.A.C.ULTA Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Acid Phosphatase, Naphthyl Phosphate

FDA classification

FDA Class 2 ·Acid Phosphatase, Naphthyl Phosphate