Company ยท US
Xomed, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2000. Name variants (Inc, Corp, punctuation) are merged.
82510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ETD | Tube, Tympanostomy | 13 |
| LXB | Hearing Aid, Bone Conduction | 6 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 5 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 5 |
| ETB | Prosthesis, Partial Ossicular Replacement | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 |
| KAM | Cannula, Sinus | 3 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 |
| EPP | Splint, Nasal | 2 |
| ETN | Stimulator, Nerve | 2 |
| HRX | Arthroscope | 2 |
| JOF | Polymer, Ent Synthetic, Porous Polyethylene | 2 |
| QPB | System, Suction, Lipoplasty For Removal | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 |
| EGJ | Device, Iontophoresis, Other Uses | 1 |
| EIB | Syringe, Irrigating (Dental) | 1 |
| EMX | Balloon, Epistaxis | 1 |
| EPY | Speculum, Ent | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 11, 2000 | K002395 | MODEL 30 CLASSIC PNEUMATONOMETER Xomed, Inc. | HKX |
| Dec 4, 2000 | K002987 | REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE Xomed, Inc. | GEI |
| Oct 17, 2000 | K002828 | XPS NITRO SYSTEM Xomed, Inc. | ERL |
| Oct 11, 2000 | K002897 | TITANIUM MIDDLE EAR PROSTHESES Xomed, Inc. | ETB |
| Jun 9, 2000 | K993653 | MICRO-FRANCE TROCARS AND ACCESSORIES Xomed, Inc. | HET |
| Jun 3, 2000 | K001148 | MEROGEL OTOLOGIC PACK Xomed, Inc. | KHJ |
| Feb 8, 2000 | K994262 | FRONTAL SINUS TREPHINATION CANNULA Xomed, Inc. | KAM |
| Jan 21, 2000 | K992855 | XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT Xomed, Inc. | QPB |
| Jan 20, 2000 | K993582 | MODIFICATION TO LASER-SHIELD II Xomed, Inc. | BTR |
| Dec 21, 1999 | K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS Xomed, Inc. | GEI |
| Dec 9, 1999 | K993112 | XOMED ENT RF SYSTEM Xomed, Inc. | GEI |
| Oct 7, 1999 | K992869 | XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE Xomed, Inc. | ETN |
| Sep 23, 1999 | K992282 | MICRO-FRANCE LIPOSUCTION CANNULAS Xomed, Inc. | QPB |
| Feb 26, 1999 | K984363 | XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM Xomed, Inc. | BTA |
| Feb 2, 1999 | K982731 | MEROGEL NASAL DRESSING AND SINUS STENT Xomed, Inc. | EMX |
| Nov 6, 1998 | K983025 | XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT Xomed, Inc. | HRX |
| Nov 3, 1998 | K982870 | EPIFILM OTOLOGIC LAMINA Xomed, Inc. | KHJ |
| Oct 21, 1998 | K983224 | XPS DRILL SYSTEM Xomed, Inc. | ERL |
| Sep 18, 1998 | K982294 | XOMED SILICONE PRE-FORM BLOCKS Xomed, Inc. | KHJ |
| Sep 4, 1998 | K982595 | NIM4 Xomed, Inc. | ETN |
| Aug 27, 1998 | K982594 | ENDO-SCRUB/ENDO-SCRUB 2 Xomed, Inc. | EOB |
| Jan 30, 1998 | K973499 | XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM Xomed, Inc. | HRX |
| Sep 29, 1997 | K973273 | XOMED T-STENT, FRONTAL SINUS STENT Xomed, Inc. | KAM |
| Sep 5, 1997 | K972453 | XPS STRAIGHTSHOT MICRORESECTOR Xomed, Inc. | ERL |
| May 16, 1997 | K971124 | TM MICRO-CATHETERS Xomed, Inc. | ETD |
| May 2, 1997 | K970910 | XOMED SILICONE BLOCK/STRIP Xomed, Inc. | KHJ |
| Apr 4, 1997 | K965233 | SHARPSITE AC Xomed, Inc. | EOB |
| Mar 10, 1997 | K964909 | ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS Xomed, Inc. | ETB |
| Jan 24, 1997 | K964484 | KARTUSH TM PATCHER Xomed, Inc. | KHJ |
| Jul 1, 1996 | K961873 | ACTIVENT ANTIMICROBIAL VENTILATION TUBES Xomed, Inc. | ETD |
| Apr 3, 1996 | K960853 | ACE SYSTEM Xomed, Inc. | EQJ |
| Aug 29, 1990 | K901016 | LASER-SHIELD II(TM) Xomed, Inc. | GEX |
| Mar 22, 1989 | K884631 | FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135) Xomed, Inc. | LRC |
| Feb 15, 1989 | K884834 | XOMED IONESTHETIZER(TM) Xomed, Inc. | EGJ |
| Nov 30, 1988 | K884056 | MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR Xomed, Inc. | LXB |
| Sep 13, 1988 | K882689 | PUNCH MYRINGOTOMY SYSTEM Xomed, Inc. | ETD |
| Jun 21, 1988 | K881382 | XOMED AUDIANT BONE CONDUCTOR Xomed, Inc. | LXB |
| Mar 14, 1988 | K875277 | ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON. Xomed, Inc. | LXB |
| Jul 2, 1987 | K872112 | XOMED PLATINUM WIRE TEFLON PISTION Xomed, Inc. | ETB |
| Jun 30, 1987 | K872168 | XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO. Xomed, Inc. | LXB |
| May 30, 1986 | K861971 | XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL Xomed, Inc. | LXB |
| Apr 3, 1986 | K855059 | AUDIANT BONE CONDUCTOR OR A.B.C. Xomed, Inc. | LXB |
| Mar 28, 1986 | K860491 | OSTEO-MESH CRANIAL FAIRING Xomed, Inc. | |
| Jan 6, 1986 | K853641 | GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE Xomed, Inc. | ETD |
| Jan 6, 1986 | K852387 | GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE Xomed, Inc. | ETD |
| Sep 12, 1983 | K832404 | RECTAL TEMP. TELEMETRY MONITOR Xomed, Inc. | FLL |
| Jul 28, 1983 | K831127 | INTRA-ORAL ARTIFICIAL LARYNX Xomed, Inc. | ESE |
| Oct 22, 1982 | K822790 | MICRO-CRAFT OSCILLATING SAW HANDPIECE Xomed, Inc. | KIJ |
| Jul 26, 1982 | K821904 | XOMED MANDIBULAR TRAY Xomed, Inc. | JAZ |
| Jul 8, 1982 | K821373 | XOMED PATENCY MONITOR Xomed, Inc. | DPW |
Newest 50 of 82.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||