gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)

FDA 510(k)

FDA Class 2 ·General Hospital

MEDIMAGE

FDA 510(k)

FDA Class 2 ·Radiology

CERCON HT

FDA 510(k)

FDA Class 2 ·Dental

PAINT- ON POLISH AGENT

FDA 510(k)

FDA Class 2 ·Dental

OSTEOGRAF/LD-300

FDA 510(k)

FDA Class 2 ·Dental

Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds

FDA 510(k)

FDA Class 2 ·Orthopedic

BonOs HV, BonOs MV, BonOs LV

FDA 510(k)

FDA Class 2 ·Orthopedic

MONOCRYSTANT PH/LES CATHETER, MODIFICATION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ADVANCED GLASS IONOMER (K-130) RESTORATIVE

FDA 510(k)

FDA Class 2 ·Dental

MTM(R) CLEAR ALIGNER

FDA 510(k)

FDA Class 2 ·Dental

POLYGRAM SOFTWARE

FDA 510(k)

FDA Class 2 ·Anesthesiology

BonOs Inject, Pedicle screw kits, Cement pusher

FDA 510(k)

FDA Class 2 ·Orthopedic

REVOIS PRO IMPLANT STSYEM

FDA 510(k)

FDA Class 2 ·Dental

ANKYLOS TEMPORARY ABUTMENT BALANCE

FDA 510(k)

FDA Class 2 ·Dental

ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS

FDA 510(k)

FDA Class 2 ·Dental

BonOs HV Genta, BonOs MV Genta, BonOs LV Genta

FDA 510(k)

FDA Class 2 ·Orthopedic

Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)

FDA 510(k)

FDA Class 2 ·Cardiovascular

URODYNAMIC ANALYSIS MODULE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SmartUs EXT-1M/3M

FDA 510(k)

FDA Class 2 ·Radiology

ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)

FDA 510(k)

FDA Class 2 ·Cardiovascular