Medical Device Manufacturer · US , Arnold , MO

Xomed, Inc.

82 submissions · 81 cleared · Since 1976
82
Total
81
Cleared
0
Denied

Xomed, Inc. — FDA 510(k) Submissions

Xomed, Inc. has submitted 82 FDA 510(k) premarket notifications since 1976, of which 81 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Tube, Tympanostomy, Hearing Aid, Bone Conduction, Polymer, Ent Synthetic-polyamide (mesh Or Foil Material), Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece, Prosthesis, Partial Ossicular Replacement . Use the specialty filter in the sidebar to narrow results.

82 devices
1–12 of 82
MODEL 30 CLASSIC PNEUMATONOMETER
K002395 · HKX Tonometer, Ac-powered · Ophthalmic
Dec 2000 126d
REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE
K002987 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2000 70d
XPS NITRO SYSTEM
K002828 · ERL Drill, Surgical, Ent... · Ear, Nose, Throat
Oct 2000 36d
TITANIUM MIDDLE EAR PROSTHESES
K002897 · ETB Prosthesis, Partial... · Ear, Nose, Throat
Oct 2000 23d
MICRO-FRANCE TROCARS AND ACCESSORIES
K993653 · HET Laparoscope, Gynecologic... · Obstetrics & Gynecology
Jun 2000 224d
MEROGEL OTOLOGIC PACK
K001148 · KHJ Polymer, Ent... · Ear, Nose, Throat
Jun 2000 54d
FRONTAL SINUS TREPHINATION CANNULA
K994262 · KAM Cannula, Sinus · General & Plastic Surgery
Feb 2000 53d
XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT
K992855 · QPB System, Suction,... · General & Plastic Surgery
Jan 2000 150d
MODIFICATION TO LASER-SHIELD II
K993582 · BTR Tube, Tracheal (w/wo... · Anesthesiology
Jan 2000 90d
MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS
K993655 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 1999 53d
XOMED ENT RF SYSTEM
K993112 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 1999 83d
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE
K992869 · ETN Stimulator, Nerve · Ear, Nose, Throat
Oct 1999 43d

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