Company ยท US
Smiths Industries Medical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 1998. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 4 |
| JOH | Tube Tracheostomy And Tube Cuff | 4 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 3 |
| BTR | Tube, Tracheal (W/Wo Connector) | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 |
| BSO | Catheter, Conduction, Anesthetic | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 |
| CAZ | Anesthesia Conduction Kit | 1 |
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 1 |
| FLL | Continuous Measurement Thermometer | 1 |
| FMJ | Manometer, Spinal-Fluid | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 20, 1998 | K972385 | FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED Smiths Industries Medical Systems, Inc. | JOH |
| Mar 14, 1997 | K965017 | REGIONAL ANESTHESIA TRAYS Smiths Industries Medical Systems, Inc. | CAZ |
| Jan 17, 1997 | K962175 | PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE Smiths Industries Medical Systems, Inc. | JOH |
| Oct 21, 1996 | K962931 | SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT Smiths Industries Medical Systems, Inc. | JKA |
| Oct 18, 1996 | K963570 | SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) Smiths Industries Medical Systems, Inc. | FMJ |
| May 2, 1996 | K960429 | PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA Smiths Industries Medical Systems, Inc. | JOH |
| Oct 26, 1995 | K953485 | SIMS CPAP SYSTEM Smiths Industries Medical Systems, Inc. | BYE |
| Oct 24, 1995 | K953483 | SIMS BLUE LINE ENDOBRONCHIAL TUBE Smiths Industries Medical Systems, Inc. | CBI |
| Sep 1, 1995 | K932947 | WALLACE Y-CAN Smiths Industries Medical Systems, Inc. | FOZ |
| Sep 1, 1995 | K932946 | WALLACE IV CANNULA Smiths Industries Medical Systems, Inc. | FOZ |
| Jul 14, 1995 | K952516 | PRO-VENT, LINE DRAW, PULSATOR Smiths Industries Medical Systems, Inc. | JKA |
| Dec 22, 1994 | K945777 | PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES Smiths Industries Medical Systems, Inc. | JKA |
| Sep 9, 1994 | K935927 | CONCORD/PORTEX EPIDURAL CATHETERS Smiths Industries Medical Systems, Inc. | BSO |
| Aug 25, 1994 | K942937 | SHARPSAFE CAT NO. 4105, 4115 AND 4120 Smiths Industries Medical Systems, Inc. | FMI |
| Mar 23, 1994 | K936133 | PERCUTANEOUS TRACHEOSTOMY KIT Smiths Industries Medical Systems, Inc. | JOH |
| Feb 28, 1994 | K935777 | SHARPSAFE, CAT. NO. 4125 Smiths Industries Medical Systems, Inc. | FMI |
| Feb 28, 1994 | K935776 | SHARPSAFE, CAT. NO. 4126 Smiths Industries Medical Systems, Inc. | FMI |
| Feb 15, 1994 | K935603 | EXTRACORPOREAL TEMPERATURE SENSOR Smiths Industries Medical Systems, Inc. | FLL |
| Feb 4, 1994 | K935628 | SHARPSAFE CAT. NO. 4127 Smiths Industries Medical Systems, Inc. | FMI |
| Jan 28, 1994 | K936134 | BERMAN AIRWAY Smiths Industries Medical Systems, Inc. | CAE |
| Jan 14, 1994 | K934465 | DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE Smiths Industries Medical Systems, Inc. | BTR |
| May 18, 1993 | K931735 | BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE Smiths Industries Medical Systems, Inc. | BTR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||