Smiths Industries Medical Systems, Inc.
Keene, NH, US
Smiths Industries Medical Systems, Inc. appears in FDA device records in Keene, NH. FDA records list 22 510(k) clearances between and , 6 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 22
- PMA records
- 6
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 22 510(k) clearances for Smiths Industries Medical Systems, Inc. between 1993 and 1998. The busiest year on record is 1994, with 10. The most recent is 1998, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 10 |
| 1995 | 5 |
| 1996 | 3 |
| 1997 | 2 |
| 1998 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K972385 | FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED | JOH | Substantially Equivalent | |
| K965017 | REGIONAL ANESTHESIA TRAYS | CAZ | Unknown | |
| K962175 | PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | |
| K962931 | SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT | JKA | Substantially Equivalent | |
| K963570 | SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) | FMJ | Substantially Equivalent | |
| K960429 | PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA | JOH | Unknown | |
| K953485 | SIMS CPAP SYSTEM | BYE | Substantially Equivalent | |
| K953483 | SIMS BLUE LINE ENDOBRONCHIAL TUBE | CBI | Substantially Equivalent | |
| K932947 | WALLACE Y-CAN | FOZ | Substantially Equivalent | |
| K932946 | WALLACE IV CANNULA | FOZ | Substantially Equivalent | |
| K952516 | PRO-VENT, LINE DRAW, PULSATOR | JKA | Substantially Equivalent | |
| K945777 | PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES | JKA | Substantially Equivalent | |
| K935927 | CONCORD/PORTEX EPIDURAL CATHETERS | BSO | Substantially Equivalent | |
| K942937 | SHARPSAFE CAT NO. 4105, 4115 AND 4120 | FMI | Substantially Equivalent | |
| K936133 | PERCUTANEOUS TRACHEOSTOMY KIT | JOH | Unknown | |
| K935777 | SHARPSAFE, CAT. NO. 4125 | FMI | Substantially Equivalent | |
| K935776 | SHARPSAFE, CAT. NO. 4126 | FMI | Substantially Equivalent | |
| K935603 | EXTRACORPOREAL TEMPERATURE SENSOR | FLL | Substantially Equivalent | |
| K935628 | SHARPSAFE CAT. NO. 4127 | FMI | Substantially Equivalent | |
| K936134 | BERMAN AIRWAY | CAE | Substantially Equivalent | |
| K934465 | DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE | BTR | Substantially Equivalent | |
| K931735 | BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE | BTR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CAEAirway, Oropharyngeal, Anesthesiology
- CAZAnesthesia Conduction Kit
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- BSOCatheter, Conduction, Anesthetic
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- LLXCatheter, Sampling, Chorionic Villus
- FLLContinuous Measurement Thermometer
- FMJManometer, Spinal-Fluid
- FMINeedle, Hypodermic, Single Lumen
- JOHTube Tracheostomy And Tube Cuff
- BTRTube, Tracheal (W/Wo Connector)
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain