MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

PRISM MEDICAL CUSTOM DIALYSIS KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P.

FDA 510(k)

FDA Class 1 ·Ophthalmic

NASAL OXYGEN CANNULA, 81585, 81587 & 81589

FDA 510(k)

FDA Class 1 ·Anesthesiology

IntraNovo 25 Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CARDIOPAC DEFIBRILLATOR 444

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nasopharyngoscope Flexible

FDA registration

EUSA GLOBAL LLC·1 product·🇺🇸 United States

Certain BellaTek Titanium Abutment

FDA registration

BIOMET 3i, LLC·1 product·🇺🇸 United States

Bipolar Cord

FDA registration

CONMED CORPORATION·1 product·🇺🇸 United States

Not-Too-Cold-To-Hold Teether

FDA registration

FRIDABABY, LLC·1 product·🇺🇸 United States

Arthrex Japan G.K. (Shinjuku)

FDA registration

Arthrex Japan G.K. (Shinjuku)·3 products·🇯🇵 Japan

Zimmer 3.1mm Eztetic Implant Gold Abutment

FDA registration

Zimmer Biomet Dental Canada Inc.·1 product·🇨🇦 Canada

T3 Pro Implants

FDA registration

Zimmer Biomet Dental Canada Inc.·1 product·🇨🇦 Canada

Adelante-S Lite, Adelante-S2, Adelante-S-RS, Adelante SII, SafeSheath II

FDA registration

OSCOR INC.·1 product·🇺🇸 United States

Pre-Angled Abutments

FDA registration

Biomet 3i Dental Iberica S.L.U.·1 product·🇪🇸 Spain

Urease and glutamic dehydrogenase, urea nitrogen

FDA registration

MERCEDES MEDICAL LLC·1 product·🇺🇸 United States

Hoveround Rehab Seating

FDA registration

HOVEROUND CORP.·1 product·🇺🇸 United States

component of AlloWedge® Instrument Set

FDA registration

RTI Surgical, Inc. (dba RTI Biologics, Inc.)·1 product·🇺🇸 United States

CS-series-FP Fluoroscopy System with optional Solid State X-Ray Imaging device (Flat Panel Detector)

FDA registration

OMEGA MEDICAL IMAGING, LLC·3 products·🇺🇸 United States