ANEROID SPHYGMOMANOMETER, DOCTOR TYPE

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIRECT DIGITIZER REGIUS MODEL 370

FDA 510(k)

FDA Class 2 ·Radiology

KONICA LASER IMAGER, DRYPRO MODEL 722

FDA 510(k)

FDA Class 2 ·Radiology

Surgical Gown, Reinforced Surgical Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BARRIER GOWN, KOOL-GARD BACKLESS GOWN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; InsightersTM Insight Workstation iS-PF1.

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surgical Gown (Sterile); Surgical Gown (Non-sterile)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Surgical Gown, Disposable Reinforced Surgical Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surgical Gown (Sterile), Surgical Gown (Non-sterile)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surgical Gown, Model: surgical gown-hp-3

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CD2 MONOCLONAL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Hematology

GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091

FDA 510(k)

FDA Class 2 ·Microbiology

CD8 MONOCLONAL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Hematology

ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.

FDA 510(k)

FDA Class 2 ·Microbiology

GEN-PROBE APTIMA COMBO 2 ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

CD4 MONOCLONAL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Hematology