Company ยท US
Treace Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 1989. Name variants (Inc, Corp, punctuation) are merged.
80510(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 | 9 |
| ETB | Prosthesis, Partial Ossicular Replacement | 6 |
| EQH | Source, Carrier, Fiberoptic Light | 4 |
| ETA | Replacement, Ossicular Prosthesis, Total | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 |
| EPY | Speculum, Ent | 2 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 2 |
| JYG | Curette, Ear | 2 |
| JYM | Inserter, Myringotomy Tube | 2 |
| KAE | Forceps, Ent | 2 |
| KAI | Mirror, Ent | 2 |
| LBM | Porous Polyethylene Ossicular Replacement | 2 |
| CCX | Support, Patient Position | 1 |
| EJB | Handle, Instrument, Dental | 1 |
| EKB | Explorer, Operative | 1 |
| EKW | Broach, Endodontic | 1 |
| EPP | Splint, Nasal | 1 |
| EPT | Microscope, Surgical | 1 |
| ESZ | Tube, Shunt, Endolymphatic | 1 |
| FSM | Tray, Surgical, Instrument | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 13, 1989 | K883727 | BUCKET PROSTHESIS PORP Treace Medical, Inc. | ETB |
| Jun 23, 1988 | K882349 | MALLET, SURGICAL Treace Medical, Inc. | HXL |
| Jan 29, 1988 | K874779 | BIPOLATOR 50 Treace Medical, Inc. | GEI |
| Sep 4, 1987 | K873154 | TREACE MAGNUM OTO-TOOL SYSTEM Treace Medical, Inc. | ERL |
| Jul 21, 1987 | K872000 | EYE GARD Treace Medical, Inc. | HOY |
| May 27, 1987 | K870765 | CANNULATED INSTRUMENT CLEANERS Treace Medical, Inc. | EKW |
| May 18, 1987 | K871706 | OPTHA PREP Treace Medical, Inc. | HMT |
| May 7, 1987 | K870759 | CLEANING SOLUTION, CATALOG NO. 8203 Treace Medical, Inc. | LRJ |
| Apr 15, 1987 | K870766 | PROSTHESIS WIRE Treace Medical, Inc. | ETB |
| Mar 18, 1987 | K870764 | SCHUKNECHT WIRE CUTTING SCISSORS Treace Medical, Inc. | |
| Mar 18, 1987 | K870763 | SUPER SCISSORS Treace Medical, Inc. | |
| Mar 18, 1987 | K870760 | BUR BRUSH Treace Medical, Inc. | |
| Mar 6, 1987 | K870762 | EAR APPLICATOR, CATALOG NO. 2229 Treace Medical, Inc. | KXF |
| Mar 6, 1987 | K870757 | OTOLOGICAL METRIC SCALE/GAUGE Treace Medical, Inc. | |
| Mar 4, 1987 | K870758 | SMALL MASTOID RETRACTOR Treace Medical, Inc. | KAL |
| Mar 3, 1987 | K870761 | EAR LOOP Treace Medical, Inc. | JYQ |
| Mar 3, 1987 | K870756 | VEIN GRAFT EAR SCISSORS Treace Medical, Inc. | JZB |
| Oct 7, 1986 | K863382 | CANNON NASAL SPLINT Treace Medical, Inc. | EPP |
| Oct 2, 1986 | K863413 | BIPOLFORCEPS Treace Medical, Inc. | GEI |
| Oct 2, 1986 | K863412 | BIPOL CABLE Treace Medical, Inc. | GEI |
| Sep 17, 1986 | K863414 | MICROBIPOLATOR Treace Medical, Inc. | GEI |
| Aug 15, 1986 | K862807 | TREACE DRILL SYSTEM Treace Medical, Inc. | ERL |
| Aug 12, 1986 | K862584 | OSTEOTOMY DRAINAGE TUBE Treace Medical, Inc. | GBS |
| Jul 30, 1986 | K862582 | TREACE MEDICAL MICRO INSTRUMENT WIPE Treace Medical, Inc. | |
| Jul 21, 1986 | K862583 | LITE TOUCH GELFOAM INSERT Treace Medical, Inc. | |
| Jun 6, 1986 | K861914 | TREACE MEDICAL FOAM INSTRUMENT PAD Treace Medical, Inc. | |
| May 30, 1986 | K861915 | SURGICAL HEAD SUPPORT Treace Medical, Inc. | CCX |
| Mar 18, 1985 | K844378 | OIL, MINERAL Treace Medical, Inc. | |
| Mar 18, 1985 | K844377 | SILICONE Treace Medical, Inc. | |
| Nov 29, 1984 | K844379 | STONE, INSTRUMENT HONING Treace Medical, Inc. | |
| Sep 20, 1984 | K834094 | AUSTIN ENDOLYMPH DISPERSMENT SHUNT Treace Medical, Inc. | ESZ |
| Aug 24, 1984 | K841357 | MICRO FLUID APPLICATOR Treace Medical, Inc. | JZF |
| Jul 18, 1984 | K841359 | FENESTRA HOOK Treace Medical, Inc. | IYL |
| Jul 18, 1984 | K841356 | ELEVATOR Treace Medical, Inc. | KAD |
| Jul 6, 1984 | K841354 | CURETTE Treace Medical, Inc. | JYG |
| Jul 6, 1984 | K841353 | CAUSSE SPONGE BOAT Treace Medical, Inc. | ETB |
| Jul 3, 1984 | K841355 | RIGHT ANGLED PICK Treace Medical, Inc. | JYT |
| May 2, 1984 | K834093 | PERFORATOR BUR Treace Medical, Inc. | |
| Nov 22, 1983 | K823910 | DONALDSON VENT TUBE Treace Medical, Inc. | ETD |
| Jun 24, 1983 | K823919 | TOTAL OSSICULAR REPLACEMENT Treace Medical, Inc. | ETA |
| Jun 24, 1983 | K823918 | AUSTIN MODIFIED PARTIAL OSSICULAR RE- Treace Medical, Inc. | ETA |
| Jun 24, 1983 | K823917 | PARTIAL OSSICULAR REPLACEMENT Treace Medical, Inc. | ETA |
| Jun 24, 1983 | K823912 | AUSTIN MODIFIED TOTAL OSSICULAR REPLACE Treace Medical, Inc. | ETA |
| Jun 16, 1983 | K831589 | VENT TUBE FORCEPS Treace Medical, Inc. | EQH |
| Jun 15, 1983 | K831590 | T-TUBE INSERTER Treace Medical, Inc. | EQH |
| Jun 15, 1983 | K831588 | INSTRUMENT GUARD CAPSULE Treace Medical, Inc. | KCT |
| Jun 2, 1983 | K830584 | SOILEAU TYTAN BOBBIN VENT TUBE Treace Medical, Inc. | ETD |
| Mar 17, 1983 | K823909 | T-TUBE VENT TUBE Treace Medical, Inc. | ETD |
| Jan 28, 1983 | K830085 | COLLAR BUTTON VENT TUBE Treace Medical, Inc. | ETD |
| Jan 28, 1983 | K823908 | GROMMET VENT TUBE Treace Medical, Inc. | ETD |
Newest 50 of 80.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||