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

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

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACIES

FDA 510(k)

FDA Class 2 ·Radiology

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BCI WW1021 PC APPLICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

BCI WW1030 PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BCI 3180 PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER

ACI PULSATING VACUUM PUMP SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SYNTHES ACIS/VERTEBRAL SPACER CR

FDA 510(k)

FDA Class 2 ·Orthopedic

AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)

FDA 510(k)

FDA Class 2 ·Hematology

BCI-100 FECAL INCONTINENCE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology