Cutter Laboratories, Inc.
Medical device manufacturer in Berkeley, CA.
39510(k) clearances
0PMA approvals
0recalls
Device types
- ELW Material, Impression 5
- CAH Filter, Bacterial, Breathing-Circuit 3
- EMA Cement, Dental 2
- ITG Bandage, Cast 2
- FOZ Catheter, Intravascular, Therapeutic… 1
- CBF Chamber, Hyperbaric 1
- EHL Point, Abrasive 1
- FKG Tray, Start/Stop (Including Contents)… 1
- KXE Prosthesis, Wrist, Hemi-, Ulnar 1
- KNX Collector, Urine, (And Accessories) For… 1
- KYJ Prosthesis, Finger, Constrained, Polymer 1
- GKF Instrument, Hematocrit, Automated 1
- GAA Needle, Aspiration And Injection, Disposable 1
- JWH Prosthesis, Knee, Patellofemorotibial… 1
- HTT Burr, Orthopedic 1
- KXZ System, Thermographic, Liquid Crystal… 1
- BWF Spirometer, Therapeutic (Incentive) 1
- EJL Bur, Dental 1
- EBH Material, Impression Tray, Resin 1
- HRY Prosthesis, Knee, Femorotibial… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K861315 | Hyperbaric Penetration Extension SetCBF · Traditional | 05/21/1986SE |
| K854106 | BaysilexELW · Traditional | 03/17/1986SE |
| K842324 | PerfourmELW · Traditional | 11/09/1984SE |
| K834106 | Intravenous Infusion ControllerLDR · Traditional | 05/30/1984SE |
| K832237 | Orthopedic Casting Tape MaxcastITG · Traditional | 08/16/1983SE |
| K823214 | Dosimetric Release Program - Admin. SetFPA · Traditional | 01/12/1983SE |
| K821326 | Cutter Bond Polycarboxylate CementEMA · Traditional | 05/28/1982SE |
| K813532 | Cutterbond Zinc Phosphate CementEMA · Traditional | 03/02/1982SE |
| K802105 | C-BladeHWE · Traditional | 09/16/1980SE |
| K802104 | C-SplintIQI · Traditional | 09/16/1980SE |
| K801652 | Total Parenteral Nutrition Set BagKPE · Traditional | 08/27/1980SE |
| K801651 | Cutter JetEFB · Traditional | 08/13/1980SE |
| K800213 | Pharmacy Additive Syringe SetKYW · Traditional | 02/26/1980SE |
| K792250 | Cutter PointsEHL · Traditional | 01/23/1980SE |
| K792207 | Peridial Peritoneal Dialysis TrayFKG · Traditional | 12/10/1979SE |
| K790125 | Ulnar Head ProthesisKXE · Traditional | 02/08/1979SE |
| K781937 | Prothesis, Metacarpal · Traditional | 01/17/1979SE |
| K781521 | Cutter Resiflex Urine MeterKNX · Traditional | 11/22/1978SE |
| K781668 | Gamma Radiation Sterilization PrecedureKYJ · Traditional | 11/03/1978SE |
| K781059 | Cutter/Compur Mini CentrifugeGKF · Traditional | 08/14/1978SE |
| K780624 | Culdocentesis TrayGAA · Traditional | 05/26/1978SE |
| K772225 | Patellar ProsthesisJWH · Traditional | 12/08/1977SE |
| K770776 | Tray, Pressure, Intracompartmental,Wick · Traditional | 08/04/1977SE |
| K770751 | Catheters, Over-The-NeedleFOZ · Traditional | 05/26/1977SE |
| K770678 | Elc-Thermo-SystemKXZ · Traditional | 05/25/1977SE |
| K770742 | Cutter Cast 7ITG · Traditional | 04/28/1977SE |
| K770619 | Exercisor, RespiratoryBWF · Traditional | 04/07/1977SE |
| K770469 | Cutter Tungsten Carbide BursEJL · Traditional | 03/16/1977SE |
| K770392 | Muffler, Air PumpCAH · Traditional | 03/07/1977SE |
| K770376 | Filter, Nebulizer, CutterCAH · Traditional | 03/01/1977SE |
| K770375 | Filter, Air, Cutter MainlineCAH · Traditional | 03/01/1977SE |
| K760753 | Cutter Jel-Alginate Impression Mat.ELW · Traditional | 10/20/1976SE |
| K760755 | Cutter Sil-Silicone Impression MatELW · Traditional | 10/15/1976SE |
| K760754 | Cutter Tray-Acrylic for Imp TraysEBH · Traditional | 10/15/1976SE |
| K760752 | Cutter Flex-Silicone Impression Mat.ELW · Traditional | 10/15/1976SE |
| K760744 | Tavernetti-TennantHRY · Traditional | 10/07/1976SE |
| K760422 | Surgical RetractorGAD · Traditional | 08/23/1976SE |
| K760236 | Bur, Surgical CarbideHTT · Traditional | 07/26/1976SE |
| K760235 | Suture Guide · Traditional | 07/26/1976SE |