Xomed, Inc.
Arnold, MO, US
Xomed, Inc. appears in FDA device records in Arnold, MO. FDA records list 35 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 35
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 35 510(k) clearances for Xomed, Inc. between 1976 and 1983. The busiest year on record is 1979, with 12. The most recent is 1983, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 3 |
| 1978 | 6 |
| 1979 | 12 |
| 1980 | 1 |
| 1981 | 3 |
| 1982 | 7 |
| 1983 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K832404 | RECTAL TEMP. TELEMETRY MONITOR | FLL | Substantially Equivalent | |
| K831127 | INTRA-ORAL ARTIFICIAL LARYNX | ESE | Substantially Equivalent | |
| K822790 | MICRO-CRAFT OSCILLATING SAW HANDPIECE | KIJ | Substantially Equivalent | |
| K821904 | XOMED MANDIBULAR TRAY | JAZ | Substantially Equivalent | |
| K821373 | XOMED PATENCY MONITOR | DPW | Substantially Equivalent | |
| K813224 | CERAVITAL CERAMIC EAR CANAL WALL PROSTH | ESF | Substantially Equivalent | |
| K820157 | XOMED THERMAL MYRINGOTOMY SYSTEM | HQP | Substantially Equivalent | |
| K813475 | XOMED MICRO-IRRIGATOR | FQH | Substantially Equivalent | |
| K813474 | MAXILL-AIR SINUS VENTILATION TUBE | KAM | Substantially Equivalent | |
| K810707 | CERAVITAL CERAMIC OSSICULAR REPL. PROS. | ETA | Substantially Equivalent | |
| K810738 | GOODE MAGNETIC NASAL SPLINT | EPP | Substantially Equivalent | |
| K810020 | PANJE VOICE PROSTHESIS | EWL | Substantially Equivalent | |
| K800728 | PAPARELL TYPE 2, BIOLITE COATED SILI- | ETD | Substantially Equivalent | |
| K792330 | XOMED MICROSURGERY BACKGROUND | Substantially Equivalent | ||
| K791680 | POPE UMBRELLA TUBE | ETD | Substantially Equivalent | |
| K791681 | THE DENVER SPLINT | EPP | Substantially Equivalent | |
| K791407 | WOMED NICRO-CRAFT POWER SYSTEM | ERL | Substantially Equivalent | |
| K791059 | POPE OTO-WICK, STERILE & NON-STERILE | KCN | Substantially Equivalent | |
| K791123 | EAR AND NOSE SPECULA | EPY | Substantially Equivalent | |
| K791122 | TISSURE RETRACTORS | GAD | Substantially Equivalent | |
| K791120 | MIDDLE EAR PICKS, HOOKS CURETTES, | GDG | Substantially Equivalent | |
| K791124 | SURGICAL SCISSORS | KBD | Substantially Equivalent | |
| K791121 | ALLIGATOR FORECPTS, CUPPED FORCEPS | JYR | Substantially Equivalent | |
| K790915 | JUHN TYM-TAP | FMH | Substantially Equivalent | |
| K790216 | VENTILATION TUBE, SHEEHY COLLAT | ETD | Substantially Equivalent | |
| K781529 | SEPTAL BUTTON | LFB | Substantially Equivalent | |
| K781418 | XOMED TRANSSPHENOIDAL HANDPIECE | ERL | Substantially Equivalent | |
| K781260 | VENTILATION TUBE SILICONE PAPARELLA TYPE | ETD | Substantially Equivalent | |
| K781259 | VENTILATION TUBE TEFLON SHEPARD TYPE | ETD | Substantially Equivalent | |
| K781258 | VENTILATION TUBE. SILI. DONALDSON TYPE | ETD | Substantially Equivalent | |
| K781257 | VENTILATION TUBE SILI. SHEPPARD TYPE | ETD | Substantially Equivalent | |
| K771727 | BIOSPONGE RECONSTRUCTION DISCS | JOF | Substantially Equivalent | |
| K771726 | BIOSPONGE STAPES PISTON | JOF | Substantially Equivalent | |
| K771725 | BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. | FEX | Substantially Equivalent | |
| K760570 | ROBINSON MIDDLE EAR PROSTHESIS | EIB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LFBButton, Nasal Septal
- KAMCannula, Sinus
- FMHContainer, Specimen, Sterile
- FLLContinuous Measurement Thermometer
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- KCNEar Wick
- DPWFlowmeter, Blood, Cardiovascular
- GDGHook, Surgical, General & Plastic Surgery
- FEXInstrument, Catheter, Punch
- KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- ESELarynx, Artificial (Battery-Powered)
- FQHLavage, Jet
- JYRNipper, Malleus
- ESFPolymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
- JOFPolymer, Ent Synthetic, Porous Polyethylene
- JAZProsthesis, Facial, Mandibular Implant
- EWLProsthesis, Laryngeal (Taub)
- ETAReplacement, Ossicular Prosthesis, Total
- GADRetractor
- KBDScissors, Nasal
- EPYSpeculum, Ent
- EPPSplint, Nasal
- EIBSyringe, Irrigating (Dental)
- ETDTube, Tympanostomy
- HQPUnit, Cautery, Thermal, Battery-Powered
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain