Company ยท US
Concord Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1989. Name variants (Inc, Corp, punctuation) are merged.
42510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FMF | Syringe, Piston | 6 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 5 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 5 |
| CBT | Arterial Blood Sampling Kit | 4 |
| BSY | Catheters, Suction, Tracheobronchial | 3 |
| CAZ | Anesthesia Conduction Kit | 3 |
| LKB | Pad, Alcohol, Device Disinfectant | 3 |
| BSO | Catheter, Conduction, Anesthetic | 1 |
| EZL | Catheter, Retention Type, Balloon | 1 |
| FMC | Patient Examination Glove | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| FNY | Basin, Emesis | 1 |
| GCB | Needle, Catheter | 1 |
| GJE | Tray, Blood Collection | 1 |
| HXD | Clamp | 1 |
| KGO | Surgeon'S Gloves | 1 |
| LIO | Device, Specimen Collection | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 16, 1989 | K883840 | DRI-VENT ARTERIAL BLOOD SAMPLING KIT Concord Laboratories, Inc. | LKB |
| Jun 29, 1987 | K871825 | MECONIUM SUCTION CATHETER Concord Laboratories, Inc. | BSY |
| Jan 6, 1987 | K864535 | TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110 Concord Laboratories, Inc. | BSY |
| Jul 3, 1986 | K862039 | CONCORD CARE TRAY Concord Laboratories, Inc. | |
| Jan 10, 1986 | K854601 | SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH Concord Laboratories, Inc. | BSO |
| Nov 13, 1985 | K854327 | SUBCUTANEOUS TUNNELING NEEDLES & HANDLES Concord Laboratories, Inc. | GCB |
| Jul 15, 1985 | K851134 | REGIONAL ANESTHESIA TRAYS Concord Laboratories, Inc. | CAZ |
| Jul 3, 1984 | K842095 | EPIDURAL TRAYS Concord Laboratories, Inc. | CAZ |
| May 23, 1984 | K841486 | ARTERIAL BLOOD SAMPLING KITS Concord Laboratories, Inc. | CBT |
| Apr 5, 1984 | K840987 | VAPORIZED HEPARIN Concord Laboratories, Inc. | CBT |
| Apr 5, 1984 | K840986 | PREFILLED PULSATOR SYRINGE Concord Laboratories, Inc. | CBT |
| Apr 3, 1984 | K840709 | MID-STREAM URINE COLLECTION SETS Concord Laboratories, Inc. | |
| Mar 19, 1984 | K833814 | SANI CATCH BA Concord Laboratories, Inc. | LIO |
| Mar 7, 1984 | K840988 | NO POUR BASIN Concord Laboratories, Inc. | |
| Jan 30, 1984 | K833993 | ALCOHOL SWABS Concord Laboratories, Inc. | LKB |
| Jan 30, 1984 | K833936 | ACETONE ALCOHOL SWABS Concord Laboratories, Inc. | LKB |
| Dec 27, 1983 | K833582 | PULSATOR ARTERIAL BLOOD SAMPLING SYRIN Concord Laboratories, Inc. | CBT |
| Sep 26, 1983 | K832778 | EPIDURAL SYRINGE Concord Laboratories, Inc. | CAZ |
| Jun 12, 1981 | K811009 | PREFILLED PULSATOR SYRINGE Concord Laboratories, Inc. | FMF |
| May 21, 1981 | K810995 | PREFILLED PULSATOR SYRINGE Concord Laboratories, Inc. | FMF |
| Aug 14, 1980 | K801814 | CATHETER SUCTION TRACHEOBRONCHIAL Concord Laboratories, Inc. | BSY |
| Dec 20, 1978 | K782090 | CLAMP, DISPOSABLE Concord Laboratories, Inc. | HXD |
| Mar 27, 1978 | K780419 | SUBCLAVIAN TRAY Concord Laboratories, Inc. | KGO |
| Dec 13, 1977 | K772218 | CATHETER, SILICONE COATED Concord Laboratories, Inc. | EZL |
| Oct 13, 1977 | K771667 | BLOOD GAS TRAY #4024 Concord Laboratories, Inc. | FMI |
| Sep 30, 1977 | K771673 | CATHETEO CARE TRAY #0242 Concord Laboratories, Inc. | FMC |
| Jul 15, 1977 | K770850 | TRAY, BLOOD GAS, ARTERIAL, #4014 Concord Laboratories, Inc. | FMF |
| Jul 14, 1977 | K770852 | SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015 Concord Laboratories, Inc. | FMF |
| Jul 14, 1977 | K770851 | SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016 Concord Laboratories, Inc. | FMF |
| Jun 24, 1977 | K771104 | URETHRAL TRAY W/OUT CAHTETER, 7650 Concord Laboratories, Inc. | FCM |
| Jun 24, 1977 | K771103 | URETHRAL TRAY W/CATHETER, 7750 Concord Laboratories, Inc. | FCM |
| Apr 15, 1977 | K770673 | COLLECTOR, SANI-CATCH, NO. 1014 Concord Laboratories, Inc. | KNX |
| Apr 15, 1977 | K770672 | COLLECTOR, SANI-CATCH, NO. 1010 Concord Laboratories, Inc. | KNX |
| Apr 5, 1977 | K770361 | TRAY, BLOOD GAS, CAT. NO. 4010 Concord Laboratories, Inc. | FMF |
| Mar 24, 1977 | K770557 | DRAINAGE BAG, 4000 ML. Concord Laboratories, Inc. | KNX |
| Mar 21, 1977 | K770497 | DRAINAGE UNIT, COMBINATION Concord Laboratories, Inc. | KNX |
| Mar 21, 1977 | K770496 | UNIVERSAL TRAY Concord Laboratories, Inc. | FCM |
| Oct 7, 1976 | K760128 | TRAY, CATHETERIZATION W/ CATHETER Concord Laboratories, Inc. | FCM |
| Oct 7, 1976 | K760127 | TRAY, CATHETERIZATION W/O CATHETER Concord Laboratories, Inc. | FCM |
| Oct 7, 1976 | K760105 | BAG, URINE COLLECTION, CLOSED SYSTEM Concord Laboratories, Inc. | KNX |
| Jul 20, 1976 | K760085 | BASIN, STERILE (#3200) Concord Laboratories, Inc. | FNY |
| Jul 16, 1976 | K760086 | TRAY, BLOOD SAMPLING (PULSATOR II) Concord Laboratories, Inc. | GJE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||