Intelli-Ox

FDA 510(k)

FDA Class 1 ·Anesthesiology

NuCath Wedge Pressure Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

TWINTRODE ELC 134 ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN

FDA 510(k)

FDA Class 2 ·Neurology

NanoOrtho NanoKnee® System

FDA 510(k)

FDA Class 2 ·Orthopedic

Foundation Dermal Regeneration Scaffold (DRS) Solo

FDA 510(k)

FDA Unclassified ·Unknown

CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

RETRACTOR

FDA 510(k)

FDA Class 2 ·Orthopedic

NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30

FDA 510(k)

FDA Class 2 ·Neurology

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS, HEALON ULTIMATE DUAL

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)-HEALON, HEALON GV, HEALON5, AND HEALON ULTIMATE DUAL PACK

10477 - Headboard/Footboard, Long Term Care beds, Light Oak, 1pr/Cs

FDA UDI

DYNAREX CORPORATION·00616784047737·

TABLE,4 CUTOUT,OAK,ADJ LGS,26-34"H(2 PC)

FDA UDI

Hausmann Enterprises, LLC·00840314809575·

10493 - Headboard/Footboard, Long Term Low Bed, Light Oak, 1pr/Cs

FDA UDI

DYNAREX CORPORATION·00616784049335·

E233502N-1 CVK Drape 250x130cm, FEN 10cm round, ADH, Bi-laminate

FDA UDI

EXACT MEDICAL MANUFACTURING, INC.·00816953020626·

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, HEALON ULTIMATE DUAL PACK, AND HEALON DUET

FDA Pre-Market Approval

Sodium Hyaluronate Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack

10480 - Headboard/Footboard, Long Term Care beds, Expandable, Light Oak, 1pr/Cs

FDA UDI

DYNAREX CORPORATION·00616784048031·

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest Wearable Defibrillator

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST