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Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM

PM O2 w/gloves ARC stock no.329704

FDA UDI
Laerdal Medical AS·07045430011748·The Pocket Mask is primarily designed for mouth...

LIME-LITE

FDA UDI
PULPDENT CORPORATION·D701LIME2·Kit: 4 x 1.2 mL syringes + 8 applicator tips Li...

LIME-LITE

FDA UDI
PULPDENT CORPORATION·D701LIME32·3 mL syringe Light cure cavity liner

NuSmile NeoMTA

FDA UDI
NUSMILE, LTD.·00862487000320·Tricalcium silicate-based cement for contact wi...

FLUOBEAM LX

FDA UDI
FLUOPTICS·B475FBLX0·Fluorescence imaging system

eXero

FDA registration
LODOX SYSTEMS (PTY) LTD.·1 product·🇿🇦 South Africa

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·INSYNC III CRT-P

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

FDA Pre-Market Approval
INSYNC III MARQUIS/PROTECT/INSYNC SENTRY/MAXIMO ICD/CONCERTO/II/MAXIMO II/CONSULTA CRT-D

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Carbomedics Prosthetic Heart Valve (CPHV)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·C & T SERIES IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 600/700/650/800/900/ RELIA/SIGMA/ENPULSE/ENRHYTHM/ADAPTA/VERSA/SENSIA IPGS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·INTEGRITY CORONARY STENT SYSTEMS

ACCU-BEAM 300W XENON LIGHT SOURCE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

FLEX-STAR V

FDA 510(k)
FDA Class 2 ·Dental

CO2 LASER BRONCHOSCOPE SET

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

POLYSTAR 79 DENTURE BASE RESIN

FDA 510(k)
FDA Class 2 ·Dental