DIA-ROOT BIO MTA

FDA 510(k)

FDA Class 2 ·Dental

BIO-CHALLENGE TEST PAK

FDA 510(k)

FDA Class 2 ·General Hospital

Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments

FDA 510(k)

FDA Class 2 ·Dental

HTx Disposable Hysteroscope System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) XPRT(TM) BALL. DIL. CATH. W/PRO/PEL(TM)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) SOLO(TM) BALL. DIL. CATH. W/PRO/PEL COAT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) FORCE(R) BALL. DIL. CATH. W/PRO/PEL COAT.

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) SPRINT(TM) BALL. DIL. CATH. W/PRO/PEL COAT

GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O

FDA 510(k)

FDA Class 2 ·Dental

BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B

FDA 510(k)

FDA Class 2 ·Orthopedic

BIO SET TM SUBSTRATE CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIO-APATITE 6140 HA PARTICLES

FDA 510(k)

FDA Class 2 ·Dental

BIO-OSS ANORGANIC BOVINE BONE

FDA 510(k)

FDA Class 2 ·Dental

BIO-MINI REVO SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

BIO-CHEM ANALYZER, MODEL 100

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TORCH BIO-BEAD SCREEN KIT

FDA 510(k)

FDA Class 2 ·Microbiology

BIO-SENSOR 01 EKG ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CMV RQ BIO-ENZABEAD KIT

FDA 510(k)

FDA Class 2 ·Microbiology