Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY FAMILY OF NEUROSTIMULATORS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC & INSYNC III CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PRODIGY/THERA I IPG

CONTINUOUS VENTILATOR

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

Sleepware G3

FDA 510(k)

FDA Class 2 ·Neurology

TRABECULO-SUPRACHOROIDAL SHUNT

FDA 510(k)

FDA Class 2 ·Ophthalmic

AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD

FDA 510(k)

FDA Class 2 ·Anesthesiology

Aplicare

FDA registration

Newview Oklahoma, Inc·1 product·🇺🇸 United States

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM ¿ MBT REVISION TIBIAL TRAYS

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS® Total Knee System - MBT Thick Tray

AMBU TUBECHECK

FDA 510(k)

FDA Class 2 ·Anesthesiology

AMBU RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Antiserum to Human IgM (muc chain specific)

FDA UDI

KENT LABORATORIES INC·B1761030·Goat antiserum to Human IgM

Tinaquant IgM Gen2

FDA UDI

Roche Diagnostics GmbH·04015630919659·

Tinaquant IgM Gen2

FDA UDI

Roche Diagnostics GmbH·04015630925742·

Poly Rb A-Hu IgM

FDA UDI

AGILENT TECHNOLOGIES SINGAPORE PTE LTD·05700572001416·Polyclonal Rabbit Anti-Human IgM

Tinaquant IgM Gen2

FDA UDI

Roche Diagnostics GmbH·04015630919635·

Tina-quant IgM Gen.2

FDA UDI

Roche Diagnostics GmbH·07613336121337·

FDA Pre-Market Approval

VIGOR(R) DR/SR PACEMAKER SYSTEM