Company ยท US
Cutter Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1986. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ELW | Material, Impression | 5 |
| CAH | Filter, Bacterial, Breathing-Circuit | 3 |
| EMA | Cement, Dental | 2 |
| ITG | Bandage, Cast | 2 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 |
| CBF | Chamber, Hyperbaric | 1 |
| EBH | Material, Impression Tray, Resin | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 |
| EHL | Point, Abrasive | 1 |
| EJL | Bur, Dental | 1 |
| FKG | Tray, Start/Stop (Including Contents), Dialysis | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 |
| GAD | Retractor | 1 |
| GKF | Instrument, Hematocrit, Automated | 1 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 |
| HTT | Burr, Orthopedic | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 |
| IQI | Orthosis, Limb Brace | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 21, 1986 | K861315 | HYPERBARIC PENETRATION EXTENSION SET Cutter Laboratories, Inc. | CBF |
| Mar 17, 1986 | K854106 | BAYSILEX Cutter Laboratories, Inc. | ELW |
| Nov 9, 1984 | K842324 | PERFOURM Cutter Laboratories, Inc. | ELW |
| May 30, 1984 | K834106 | INTRAVENOUS INFUSION CONTROLLER Cutter Laboratories, Inc. | LDR |
| Aug 16, 1983 | K832237 | ORTHOPEDIC CASTING TAPE MAXCAST Cutter Laboratories, Inc. | ITG |
| Jan 12, 1983 | K823214 | DOSIMETRIC RELEASE PROGRAM - ADMIN. SET Cutter Laboratories, Inc. | FPA |
| May 28, 1982 | K821326 | CUTTER BOND POLYCARBOXYLATE CEMENT Cutter Laboratories, Inc. | EMA |
| Mar 2, 1982 | K813532 | CUTTERBOND ZINC PHOSPHATE CEMENT Cutter Laboratories, Inc. | EMA |
| Sep 16, 1980 | K802105 | C-BLADE Cutter Laboratories, Inc. | HWE |
| Sep 16, 1980 | K802104 | C-SPLINT Cutter Laboratories, Inc. | IQI |
| Aug 27, 1980 | K801652 | TOTAL PARENTERAL NUTRITION SET BAG Cutter Laboratories, Inc. | KPE |
| Aug 13, 1980 | K801651 | CUTTER JET Cutter Laboratories, Inc. | EFB |
| Feb 26, 1980 | K800213 | PHARMACY ADDITIVE SYRINGE SET Cutter Laboratories, Inc. | KYW |
| Jan 23, 1980 | K792250 | CUTTER POINTS Cutter Laboratories, Inc. | EHL |
| Dec 10, 1979 | K792207 | PERIDIAL PERITONEAL DIALYSIS TRAY Cutter Laboratories, Inc. | FKG |
| Feb 8, 1979 | K790125 | ULNAR HEAD PROTHESIS Cutter Laboratories, Inc. | KXE |
| Jan 17, 1979 | K781937 | PROTHESIS, METACARPAL Cutter Laboratories, Inc. | |
| Nov 22, 1978 | K781521 | CUTTER RESIFLEX URINE METER Cutter Laboratories, Inc. | KNX |
| Nov 3, 1978 | K781668 | GAMMA RADIATION STERILIZATION PRECEDURE Cutter Laboratories, Inc. | KYJ |
| Aug 14, 1978 | K781059 | CUTTER/COMPUR MINI CENTRIFUGE Cutter Laboratories, Inc. | GKF |
| May 26, 1978 | K780624 | CULDOCENTESIS TRAY Cutter Laboratories, Inc. | GAA |
| Dec 8, 1977 | K772225 | PATELLAR PROSTHESIS Cutter Laboratories, Inc. | JWH |
| Aug 4, 1977 | K770776 | TRAY, PRESSURE, INTRACOMPARTMENTAL,WICK Cutter Laboratories, Inc. | |
| May 26, 1977 | K770751 | CATHETERS, OVER-THE-NEEDLE Cutter Laboratories, Inc. | FOZ |
| May 25, 1977 | K770678 | ELC-THERMO-SYSTEM Cutter Laboratories, Inc. | KXZ |
| Apr 28, 1977 | K770742 | CUTTER CAST 7 Cutter Laboratories, Inc. | ITG |
| Apr 7, 1977 | K770619 | EXERCISOR, RESPIRATORY Cutter Laboratories, Inc. | BWF |
| Mar 16, 1977 | K770469 | CUTTER TUNGSTEN CARBIDE BURS Cutter Laboratories, Inc. | EJL |
| Mar 7, 1977 | K770392 | MUFFLER, AIR PUMP Cutter Laboratories, Inc. | CAH |
| Mar 1, 1977 | K770376 | FILTER, NEBULIZER, CUTTER Cutter Laboratories, Inc. | CAH |
| Mar 1, 1977 | K770375 | FILTER, AIR, CUTTER MAINLINE Cutter Laboratories, Inc. | CAH |
| Oct 20, 1976 | K760753 | CUTTER JEL-ALGINATE IMPRESSION MAT. Cutter Laboratories, Inc. | ELW |
| Oct 15, 1976 | K760755 | CUTTER SIL-SILICONE IMPRESSION MAT Cutter Laboratories, Inc. | ELW |
| Oct 15, 1976 | K760754 | CUTTER TRAY-ACRYLIC FOR IMP TRAYS Cutter Laboratories, Inc. | EBH |
| Oct 15, 1976 | K760752 | CUTTER FLEX-SILICONE IMPRESSION MAT. Cutter Laboratories, Inc. | ELW |
| Oct 7, 1976 | K760744 | TAVERNETTI-TENNANT Cutter Laboratories, Inc. | HRY |
| Aug 23, 1976 | K760422 | SURGICAL RETRACTOR Cutter Laboratories, Inc. | GAD |
| Jul 26, 1976 | K760236 | BUR, SURGICAL CARBIDE Cutter Laboratories, Inc. | HTT |
| Jul 26, 1976 | K760235 | SUTURE GUIDE Cutter Laboratories, Inc. |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||