BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

Nasal Alar SpO2 Sensor

FDA 510(k)

FDA Class 2 ·Cardiovascular

NeoMatriX Wound Matrix

FDA 510(k)

FDA Unclassified ·Unknown

HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO

FDA 510(k)

FDA Unclassified ·Unknown

LaborView LV1000

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SAM JUNCTIONAL TOURNIQUET

FDA 510(k)

FDA Class 2 ·Cardiovascular

SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)

FDA 510(k)

FDA Class 2 ·Hematology

DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO

FDA 510(k)

FDA Class 2 ·Neurology

FIXATION PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

FOCUS-GHB

FDA 510(k)

FDA Class 2 ·Hematology

FRAGMENT PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PRIMAGARD Isolation Gown (AAMI PB70 Level 3)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200

FDA 510(k)

FDA Class 1 ·Dental

ORTHOPEDIC FIXATION SYSTEMS

FDA 510(k)

FDA Class 2 ·Orthopedic

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Edora 8, Evity 8, Enitra 8, Enticos 8 HF-T QPs,Edora 8, Evity 8, Enitra 8, Enticos 8 HF-Ts and PSW 1601.U Pacemaker/ICD/

PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT

FDA 510(k)

FDA Class 2 ·Immunology

Syringe, piston

FDA registration

CROSSMED MEDICAL DEVICE CO., LTD·1 product·🇻🇬 Virgin Islands, British

LUMBAR PUNCTURE NEEDLE

FDA registration

CROSSMED MEDICAL DEVICE CO., LTD·1 product·🇻🇬 Virgin Islands, British

ENTERAL SYRINGES

FDA registration

CROSSMED MEDICAL DEVICE CO., LTD·1 product·🇻🇬 Virgin Islands, British

ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular