RAMI TAN ULTRAVIOLET B BOOTH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RAMI ULTRAVIOLET A BOOTH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GALVANIC UNIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

IPD Dental Implant Abutments

FDA 510(k)

FDA Class 2 ·Dental

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Protective Gown AAMI Level 4

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Isolation Gown AAMI Level 3

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AAMI Level 4 Protective; Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPD Dental Implant Abutments

FDA 510(k)

FDA Class 2 ·Dental

Paneffort AAMI Level 3 Isolation Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Eon Aligner

FDA 510(k)

FDA Class 2 ·Dental

Telescope Guide Extension Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

SelectSite C304-HIS Deflectable Catheter System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRIMAGARD Isolation Gown (AAMI PB70 Level 3)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DEPUY M-SPEC 36MM FEMORAL HEADS

FDA 510(k)

FDA Class 2 ·Orthopedic

SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery