Bentley Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 55
- Inspections
- 9
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K931967 | HE-30 GOLD | July 13, 1993 |
| K913956 | BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30 | January 17, 1992 |
| K913692 | VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) | November 15, 1991 |
| K903641 | QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q | November 9, 1990 |
| K894826 | UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF | February 28, 1990 |
| K874867 | CATR(TM)-H CARDIOTOMY HOLDER | February 2, 1988 |
| K874841 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER | February 2, 1988 |
| K874618 | BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER | January 19, 1988 |
| K823359 | OXYGEN CONSUMPTION MONITOR #OCM-0100 | January 5, 1983 |
| K823273 | BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. | January 5, 1983 |
| K823456 | OXYGENATORS #BOS-10, 105, 5S | December 30, 1982 |
| K823272 | VENOUS RESERVOIR BAG #BMR-1400 | December 30, 1982 |
| K822803 | BLOOD OXYGENATORS #BOS-105S BOS-5S W/ | November 1, 1982 |
| K821416 | DISPOSABLE BLOOD PRESSURE TRANSDUCER | July 2, 1982 |
| K820044 | ARTERIAL BLOOD FILTER, #AF-1025 | June 29, 1982 |
| K820343 | ARTERIAL BLOOD FILTER MODEL #AF-1040 | June 17, 1982 |
| K820679 | PEDIATRIC ARTERIAL BLOOD FILTER #AF-540 | June 17, 1982 |
| K821495 | DISPOSABLE BLOOD LINE CONNECTORS | May 27, 1982 |
| K820243 | CONTINUOUS BLOOD PROCESSOR CBP-6000 & | March 25, 1982 |
| K820342 | PHYSIOLOGICAL PRESSURE TRANSDUCER #900 | March 4, 1982 |