Company ยท US
Parke-Davis Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1986. Name variants (Inc, Corp, punctuation) are merged.
47510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 14 |
| BSO | Catheter, Conduction, Anesthetic | 3 |
| DYG | Catheter, Flow Directed | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 |
| FRC | Indicator, Biological Sterilization Process | 2 |
| KGO | Surgeon'S Gloves | 2 |
| KRA | Catheter, Continuous Flush | 2 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 |
| DYB | Introducer, Catheter | 1 |
| EFQ | Gauze/Sponge, Internal | 1 |
| EQL | Laryngostroboscope | 1 |
| EYQ | Garment, Protective, For Incontinence | 1 |
| FLL | Continuous Measurement Thermometer | 1 |
| GDZ | Handle, Scalpel | 1 |
| HHD | Pad, Menstrual, Unscented | 1 |
| ILG | Stocking, Elastic | 1 |
| IPG | Shoe, Cast | 1 |
| IQP | Rotator, Transverse | 1 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 4, 1986 | K861725 | INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT Parke-Davis Co. | FOZ |
| Aug 29, 1986 | K862119 | DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR Parke-Davis Co. | DYG |
| Jun 18, 1986 | K855120 | ATI DISPOSABLE BIOLOGICAL TEST PACK Parke-Davis Co. | FRC |
| Mar 31, 1986 | K860570 | ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE Parke-Davis Co. | KRA |
| Mar 18, 1986 | K860290 | VIAPIC CENTRAL LINE CATHETER Parke-Davis Co. | FOZ |
| Nov 1, 1985 | K852192 | DISPOSABLE STEAM BIOLOGICAL TEST PACK Parke-Davis Co. | FRC |
| Aug 19, 1985 | K841967 | DESERET THERMODILUTION CARDIAC OUTPUT Parke-Davis Co., CA | DXG |
| Jun 14, 1985 | K851327 | DESERET ARTERIAL CATHETER Parke-Davis Co. | FOZ |
| Jun 7, 1985 | K852078 | SPECTRUM(TENTATIVE) Parke-Davis Co. | FOZ |
| May 16, 1985 | K844840 | DESERET INTRODUCER SET Parke-Davis Co. | DYB |
| Mar 11, 1985 | K850505 | DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER Parke-Davis Co. | BSO |
| Mar 5, 1985 | K850439 | DESERET EPIDURAL CATHETER Parke-Davis Co. | BSO |
| Dec 3, 1984 | K843033 | DESERET INTRAVASCULAR CATHETER Parke-Davis Co. | FOZ |
| Nov 28, 1984 | K844219 | DESERET DENTRAL LINE CATHETER Parke-Davis Co. | FOZ |
| Nov 28, 1984 | K844113 | DESERET SUBCLAVIAN JUGULAR CATHETER SET Parke-Davis Co. | FOZ |
| Aug 6, 1984 | K841968 | DESERET DISPOSABLE PRESSURE TRANSDUCER Parke-Davis Co. | DRS |
| Jun 11, 1984 | K841317 | DESERET HEPARIN COATED FLOW DIRECTED Parke-Davis Co. | DYG |
| Jun 11, 1984 | K841251 | DESERET HEPARIN COATED FLOW CATH Parke-Davis Co. | DYG |
| May 9, 1984 | K841168 | STERILIZATION PROCESS INDICATOR Parke-Davis Co., CA | JOJ |
| Apr 17, 1984 | K840958 | DESERET LONG TERM INDWELLING CATHETER Parke-Davis Co. | LJS |
| Mar 22, 1984 | K840116 | DESERET INFANT CENTRAL VENOUS CATHE- Parke-Davis Co. | FOZ |
| Mar 19, 1984 | K840862 | DESERET CENTRAL VENOUS CATHETER Parke-Davis Co. | FOZ |
| Mar 19, 1984 | K840355 | DESERET MULTILUMEN SUBCLAVIAN JUGULAR Parke-Davis Co., CA | FOZ |
| Mar 19, 1984 | K840183 | DESERET MULTILUMEN SUBCLAVIAN JUGULAR Parke-Davis Co., CA | FOZ |
| Mar 19, 1984 | K834227 | DESERET SUBCLAVIAN JUGULAR CATH. SET Parke-Davis Co. | FOZ |
| Feb 13, 1984 | K834393 | DESERET NEONATAL CATHETER SET Parke-Davis Co. | FOZ |
| Feb 4, 1984 | K833976 | VANISH Parke-Davis Co. | KGO |
| Jan 13, 1984 | K834472 | DESERET EPIDURAL CATHETER Parke-Davis Co. | |
| Jan 13, 1984 | K832352 | 3-DAY RELEASE OF ETHYLENE OXIDE DEVICE Parke-Davis Co. | BSO |
| Nov 21, 1983 | K833135 | INTRACATH INTRAVENOUS CATHETER UNIT Parke-Davis Co. | FOZ |
| Sep 12, 1983 | K832058 | ANGIO-FLO CONTIN-ARTERIAL FLUSH DEV. Parke-Davis Co. | KRA |
| Jan 27, 1983 | K823064 | INTRACATH-DA INTRAVENOUS CATH. PLACEMENT Parke-Davis Co. | DQO |
| Jan 17, 1983 | K823086 | DESERET SURGEON'S GLOVE ACCESSORY Parke-Davis Co. | KGO |
| Dec 15, 1982 | K823065 | INTRA CATH-DSA INTRAVENOUS CATH PLACE. Parke-Davis Co. | DQO |
| Nov 17, 1982 | K823066 | DESERT INSYTE-A HYPERTHERMIA SENSOR ACC Parke-Davis Co. | FLL |
| Jan 8, 1979 | K782148 | HR UNIT Parke-Davis Co. | IQP |
| Jul 27, 1978 | K781031 | AEROPLAST DRESSING Parke-Davis Co. | KMF |
| Jul 14, 1977 | K771036 | SHAVE PREP TRAY Parke-Davis Co. | KKX |
| Mar 28, 1977 | K770466 | STOCKINGS, RVS TM Parke-Davis Co. | EQL |
| Dec 21, 1976 | K761035 | SURGICAL BLADE HANDLES Parke-Davis Co. | GDZ |
| Nov 11, 1976 | K760924 | TUCKS POLYPAD MATERNITY CARE PAD Parke-Davis Co. | HHD |
| Oct 20, 1976 | K760817 | ORTHOPEDIC TUBULAR STOCKINETTE Parke-Davis Co. | ILG |
| Sep 27, 1976 | K760578 | BALANCED CAST SOLE Parke-Davis Co. | IPG |
| Aug 11, 1976 | K760342 | RAZOR, SCHICK DISPOSABLE Parke-Davis Co. | LDQ |
| Jul 20, 1976 | K760164 | UNDERPAD, DISPOSABLE POLYPROPY. (UNILUX) Parke-Davis Co. | EYQ |
| Jul 16, 1976 | K760016 | SURGICAL BLADES (BEAVER) Parke-Davis Co. | |
| Jul 15, 1976 | K760113 | SPONGE, LAPAROTOMY GAUZE Parke-Davis Co. | EFQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||