Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers

FDA 510(k)

FDA Class 2 ·General Hospital

AUTOZYME SCREEN

FDA 510(k)

FDA Class 2 ·Immunology

3DNET SUITE

FDA 510(k)

FDA Class 2 ·Radiology

truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aneroid Sphygmomanometer

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)

FDA 510(k)

FDA Class 2 ·Cardiovascular

EPICARDIA 4000

FDA 510(k)

FDA Class 2 ·Cardiovascular

MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA

FDA 510(k)

FDA Class 2 ·Cardiovascular

MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

ASFORA BULLET CAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ASFORA BULLET CAGE

FDA 510(k)

FDA Class 2 ·Orthopedic

TAMCENAN OCULAR EXPLANTS AND BANDS

FDA 510(k)

FDA Class 2 ·Ophthalmic

MUELLER HINTON AGAR

FDA 510(k)

FDA Class 2 ·Microbiology

Portare System (FA-001)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat