BOEHRINGER MANNHEIM IGM ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

COBAS STANDARDS FOR CALCIUM-IN-ORGANIC

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX

FDA 510(k)

FDA Class 2 ·Dental

GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC

FDA 510(k)

FDA Class 2 ·Dental

Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G

FDA 510(k)

FDA Class 2 ·Dental

CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

HOLLOW FIBER DIALYZER, BIO CARE PS 130

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B

FDA 510(k)

FDA Class 2 ·Orthopedic

Bio-Medicus Life Support Catheter and Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER

FDA 510(k)

FDA Class 2 ·Neurology

BIO-RAY SDX DIGITAL X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS

FDA 510(k)

FDA Class 2 ·Orthopedic

JEL BIOS 18 (CODE NAME RD- 1214)

FDA 510(k)

FDA Class 2 ·Dental

Bio Guard Air/Water & Suction Valves

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

JEL BIOS 10 (CODE NAME RD-1801)

FDA 510(k)

FDA Class 2 ·Dental

NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

JEL BIOS 90 (CODE NAME RD-2401)

FDA 510(k)

FDA Class 2 ·Dental

BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052

FDA 510(k)

FDA Class 2 ·Clinical Chemistry