CHRONODYNAMICS DATA RECORDER (CDR)-100

FDA 510(k)

FDA Class 2 ·General Hospital

Comfort EC710

FDA 510(k)

FDA Class 2 ·Radiology

Xsert Lumbar Expandable Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AtriClip LAA Exclusion System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A

FDA 510(k)

FDA Class 2 ·Radiology

VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS

FDA 510(k)

FDA Class 2 ·Dental

VIS-U-ALL II SELF SEAL POUCH

FDA 510(k)

FDA Class 2 ·General Hospital

R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

NOVOHIP TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SWEET DREEMS SIMULATOR

FDA 510(k)

FDA Class 2 ·General Hospital

MODEL 35-B ALL LEVEL COT

FDA 510(k)

FDA Class 2 ·General Hospital

ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW,

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GII SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FLEXIFLO NASOENTERIC FEEDING TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRACARE

FDA 510(k)

FDA Class 2 ·General Hospital

MIM – Dose Analysis

FDA 510(k)

FDA Class 2 ·Radiology

BROWNE OPA TEST STRIP

FDA 510(k)

FDA Class 2 ·General Hospital