BIO-ABSORBABLE CORKSCREW MODEL AR-1920B

FDA 510(k)

FDA Class 2 ·Orthopedic

ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

1990A BIO-RESISTANCE BODY COMPOSITION ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000

FDA 510(k)

FDA Class 2 ·Neurology

BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Handheld VitalSigns Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Heel Stick Safety Lancet (HHZ-II, HHZ-III)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Yushan X-Ray Flat Panel Detector with DROC

FDA 510(k)

FDA Class 2 ·Radiology

Safety Lancet (XXXV)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Electric Wheelchair (MP201C); Electric Wheelchair (MP201L)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Ultrasonic Mesh Nebulizer

FDA 510(k)

FDA Class 2 ·Anesthesiology

Yushan X-Ray Flat Panel Detector

FDA 510(k)

FDA Class 2 ·Radiology

Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MSC SFM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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