Company ยท US
Ackrad Laboratories
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2002. 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 |
|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | 6 |
| BSY | Catheters, Suction, Tracheobronchial | 4 |
| BZD | Ventilator, Non-Continuous (Respirator) | 4 |
| BSR | Stylet, Tracheal Tube | 2 |
| CBH | Device, Fixation, Tracheal Tube | 2 |
| JAY | Support, Breathing Tube | 2 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 |
| KOD | Catheter, Urological | 2 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 |
| BZC | Calculator, Pulmonary Function Data | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 |
| CCT | Applicator (Laryngo-Tracheal), Topical Anesthesia | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 |
| FMF | Syringe, Piston | 1 |
| FQH | Lavage, Jet | 1 |
| HIG | Insufflator, Hysteroscopic | 1 |
| IME | Pack, Hot Or Cold, Reusable | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 |
| KFG | Antiserum, Positive Control, Aspergillus Spp. | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 21, 2002 | K021272 | SIB CATHETER, MODEL 61-7005 Ackrad Laboratories | LKF |
| Apr 24, 2002 | K020954 | H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY Ackrad Laboratories | LKF |
| Apr 16, 2002 | K020951 | H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 Ackrad Laboratories | LKF |
| Apr 9, 1997 | K970492 | INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER Ackrad Laboratories | LKF |
| Aug 8, 1996 | K961752 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) Ackrad Laboratories | LKF |
| Apr 23, 1996 | K952542 | ACKRAD ESOPHAGEAL BALLOON CATHETER SET Ackrad Laboratories | BZC |
| Apr 23, 1996 | K940176 | ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION Ackrad Laboratories | MFD |
| Aug 29, 1995 | K953034 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) Ackrad Laboratories | LKF |
| Mar 11, 1992 | K915813 | ACKRAD ERCP CONTRAST DELIVERY SET Ackrad Laboratories | FGE |
| Jul 1, 1991 | K904499 | NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) Ackrad Laboratories | KFG |
| Jun 24, 1991 | K911780 | INFANT NASAL CANNULAE ASSEMBLY, MODIFIED Ackrad Laboratories | BZD |
| Jun 29, 1990 | K901574 | ACKRAD MPR DRAINAGE CATHETER SET Ackrad Laboratories | KNT |
| Oct 30, 1989 | K895031 | MODIFIED INFANT NASAL CANNULAE ASSEMBLY Ackrad Laboratories | BZD |
| Jul 15, 1988 | K881680 | ACKRAD H/S PROCEDURE TRAY Ackrad Laboratories | HIG |
| Mar 4, 1988 | K880161 | ACKRAD PEDIATRIC C.P.A.P. SYSTEM Ackrad Laboratories | BYE |
| Dec 29, 1987 | K874312 | ACKRAD RETROGRADE URETHROGRAPHY SET Ackrad Laboratories | KOD |
| Dec 29, 1987 | K874293 | ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET Ackrad Laboratories | KOD |
| Jul 21, 1987 | K872277 | TRAKEFIT TRACHEOSTOMY TUBE HOLDER Ackrad Laboratories | CBH |
| Apr 9, 1987 | K864818 | ACKRAD TDI SET Ackrad Laboratories | KRB |
| Apr 6, 1987 | K871069 | MODIFIED HYSTEROSALPINGOGRAPY SET Ackrad Laboratories | KNA |
| Feb 10, 1987 | K865108 | N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE Ackrad Laboratories | BSR |
| Jan 10, 1986 | K854320 | ACKRAD ORAL SUCTION TUBE Ackrad Laboratories | BSY |
| Jun 26, 1985 | K852154 | ACKRAD SIALOGRAPHY CATHETER Ackrad Laboratories | |
| Mar 25, 1985 | K850784 | BRONCHITRAC L Ackrad Laboratories | BSY |
| Feb 14, 1985 | K850309 | COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK Ackrad Laboratories | JAY |
| Dec 17, 1984 | K844557 | ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE Ackrad Laboratories | BSR |
| Sep 19, 1984 | K842231 | ACKRAD HYSTEROSALPINGOGRAPHY SET Ackrad Laboratories | KNA |
| Jul 26, 1984 | K841773 | INFANT NASAL CANNULAE ASSEMBLY Ackrad Laboratories | BZD |
| Apr 17, 1984 | K840490 | FLUID REMOVAL ASSEMBLY Ackrad Laboratories | FMF |
| Feb 10, 1984 | K840056 | PEDIATRIC INTUBATION CIRCUIT Ackrad Laboratories | CAI |
| Dec 29, 1983 | K834089 | COMFIT Ackrad Laboratories | JAY |
| Dec 8, 1983 | K833633 | BRONCHITRAC DF DUAL RESP/CATHETER Ackrad Laboratories | BSY |
| Jan 28, 1983 | K823936 | CPAP INFANT NASAL CANNULAE SET Ackrad Laboratories | BZD |
| Oct 4, 1982 | K822398 | ACKRAD BRONCHITRAC Ackrad Laboratories | BSY |
| Sep 9, 1982 | K822228 | GASTRO VAGE SET FOR GASTRIC LAVAGE Ackrad Laboratories | KNT |
| Apr 26, 1982 | K820937 | ACKRAD FLUID CONNECTING SET Ackrad Laboratories | LHI |
| Feb 5, 1982 | K813607 | ACKRAD N-DO VAGE TUBE Ackrad Laboratories | FQH |
| Dec 9, 1981 | K813103 | ACKRAD INCISION & DRAIN SET Ackrad Laboratories | KDD |
| Jun 2, 1981 | K811185 | N-D0-SURE Ackrad Laboratories | CBH |
| Feb 26, 1981 | K810059 | ENDO-MED TUBE FOR ENDOTRACHEAL MED Ackrad Laboratories | CCT |
| Feb 17, 1981 | K810209 | IRRIJET Ackrad Laboratories | KYZ |
| Jan 22, 1979 | K790009 | ICE PACK, REUSABLE FLEXIBLE Ackrad Laboratories | IME |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||