Company ยท US
Mallinckrodt Medical
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2008. Name variants (Inc, Corp, punctuation) are merged.
43510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | 7 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 5 |
| CAH | Filter, Bacterial, Breathing-Circuit | 5 |
| DQY | Catheter, Percutaneous | 5 |
| BTR | Tube, Tracheal (W/Wo Connector) | 4 |
| DQO | Catheter, Intravascular, Diagnostic | 3 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 2 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 |
| BSJ | Mask, Gas, Anesthetic | 1 |
| BSY | Catheters, Suction, Tracheobronchial | 1 |
| BZA | Connector, Airway (Extension) | 1 |
| CBK | Ventilator, Continuous, Facility Use | 1 |
| DQX | Wire, Guide, Catheter | 1 |
| DWJ | System, Thermal Regulating | 1 |
| DXT | Injector And Syringe, Angiographic | 1 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 1 |
| FRQ | Tube, Levine | 1 |
| KPY | Shield, Protective, Personnel | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 2008 | K082520 | SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES Mallinckrodt Medical | BTR |
| Jun 16, 2005 | K051416 | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA Mallinckrodt Medical | JOH |
| Dec 29, 1997 | K972258 | HI-CARE CLOSED SUCTION SYSTEM Mallinckrodt Medical | BSY |
| Sep 25, 1997 | K971267 | SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF Mallinckrodt Medical | JOH |
| Jun 26, 1997 | K963732 | PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA Mallinckrodt Medical | JOH |
| Mar 28, 1997 | K955721 | CUFFED OROPHARYNGEAL AIRWAY (COPA) Mallinckrodt Medical | CAE |
| Mar 20, 1997 | K965132 | HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES Mallinckrodt Medical | BTR |
| Nov 26, 1996 | K962045 | ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT Mallinckrodt Medical | CAH |
| Oct 4, 1996 | K962173 | SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES Mallinckrodt Medical | JOH |
| Mar 13, 1996 | K955680 | SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED Mallinckrodt Medical | JOH |
| Jan 24, 1996 | K954749 | MALLINCKRODT SHILEY 15MM CAP Mallinckrodt Medical | JOH |
| Dec 6, 1995 | K954146 | UTK-DTE AUTILARY SHIELD Mallinckrodt Medical | KPY |
| Oct 24, 1995 | K953400 | GUEDEL AIRWAY Mallinckrodt Medical | CAE |
| Aug 11, 1995 | K953295 | ANESTHESIA FACE MASK Mallinckrodt Medical | BSJ |
| Jun 8, 1995 | K952036 | FLEXLIFE Mallinckrodt Medical | BYD |
| Jan 13, 1995 | K945513 | MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE Mallinckrodt Medical | JOH |
| Nov 15, 1994 | K943739 | SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER Mallinckrodt Medical | DQO |
| Sep 19, 1994 | K943276 | WARMTOUCH PLASTIC WARMING COVER Mallinckrodt Medical | DWJ |
| Sep 8, 1994 | K944124 | SPIROBAC ADAPTERS Mallinckrodt Medical | CAH |
| Aug 22, 1994 | K942794 | HYGROLIFE Mallinckrodt Medical | BYD |
| Aug 22, 1994 | K942392 | AIRWAY CONNECTOR WITH FLEX TUBE Mallinckrodt Medical | BZA |
| May 20, 1994 | K941676 | STERIVENT AND STERIVENT S Mallinckrodt Medical | CAH |
| Apr 19, 1994 | K941585 | HYGROSTER Mallinckrodt Medical | BYD |
| Apr 19, 1994 | K941536 | BARRIERBAC AND BARRIERBAC S Mallinckrodt Medical | CAH |
| Apr 15, 1994 | K941535 | TRACHEOLIFE Mallinckrodt Medical | BYD |
| Apr 15, 1994 | K941381 | HYGROBAC,S HYGROBOY AND HYGROBABY Mallinckrodt Medical | CAH |
| Apr 11, 1994 | K941246 | RAE II TRACHEAL TUBE Mallinckrodt Medical | BTR |
| Apr 7, 1994 | K934685 | SOFTTOUCH GUIDE CATHETER Mallinckrodt Medical | DQY |
| Oct 6, 1993 | K931479 | SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER Mallinckrodt Medical | DQO |
| Jul 8, 1993 | K932280 | RAE(R) II TRACHEAL TUBE Mallinckrodt Medical | BTR |
| May 27, 1993 | K923538 | MON-A-THERM FOLEY KIT Mallinckrodt Medical | FCM |
| Mar 8, 1993 | K922946 | VAPORTEMP HEAT AND MOISTURE EXCHANGER Mallinckrodt Medical | BYD |
| May 8, 1992 | K914887 | ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT Mallinckrodt Medical | FRQ |
| Jul 30, 1991 | K912199 | SOFTTOUCH(R) GUIDING CATHETER Mallinckrodt Medical | DQY |
| Jul 30, 1991 | K912191 | SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP Mallinckrodt Medical | DQY |
| Mar 4, 1991 | K902405 | MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR Mallinckrodt Medical | CBK |
| Feb 25, 1991 | K905548 | PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE Mallinckrodt Medical | DQX |
| Feb 5, 1991 | K905547 | SOFTOUCH GUIDING CATHETER Mallinckrodt Medical | DQY |
| Jan 30, 1991 | K905773 | PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER Mallinckrodt Medical | LIT |
| Dec 3, 1990 | K904212 | HIGH-PRESSURE CONNECTOR TUBE Mallinckrodt Medical | DXT |
| Dec 3, 1990 | K902317 | PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH. Mallinckrodt Medical | LIT |
| Oct 23, 1990 | K903330 | MALLINCKRODT MEDICAL, INC., INFUSSION CATHERTER Mallinckrodt Medical | DQY |
| Sep 28, 1990 | K902953 | SOFTOUCH GUIDING CATHETER Mallinckrodt Medical | DQO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||