Panels › Hematology › Product code BSB · Class 2
Warmer, Blood, Non-Electromagnetic Radiation
Regulation 864.9205
0510(k)s in 12 months (14 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in BSB
| Company | 510(k)s | Recalls |
|---|---|---|
| Belmont Instrument Corp. | 5 | 0 |
| Estill Medical Technologies, Inc. | 2 | 1 |
| Stihler Electronic GmbH | 2 | 0 |
| 3M Company | 0 | 1 |
| Augustine Medical, Inc. | 1 | 0 |
| Baxter Healthcare Corp | 1 | 0 |
| Gorman Rupp Industries | 1 | 0 |
| Nats Corp. | 1 | 0 |
| Travenol Laboratories, S.A. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 2011 | K112639 | THE BELMONT BUDDY LITE FLUID WARMER Belmont Instrument Corp. | BSB |
| Mar 26, 2009 | K090508 | THE BELMONT BUDDY LITE FLUID WARMER Belmont Instrument Corp. | BSB |
| Oct 19, 2006 | K062774 | BELMONT BUDDY PLUS FLUID WARMER Belmont Instrument Corp. | BSB |
| Oct 13, 2005 | K052547 | BELMONT BUDDY FLUID WARMER Belmont Instrument Corp. | BSB |
| Jul 2, 2003 | K031478 | MICROHEATER Belmont Instrument Corp. | BSB |
| Mar 5, 2002 | K020060 | ASTOFLO Nats Corp. | BSB |
| Jul 26, 2001 | K012031 | MODIFICATION TO THERMAL ANGEL Estill Medical Technologies, Inc. | BSB |
| Sep 3, 1999 | K991159 | PRISMATHERM II, ASTOLINE Stihler Electronic GmbH | BSB |
| Sep 2, 1999 | K991160 | ASTOTHERM PLUS, ASTOTUBES, ASTOLINE Stihler Electronic GmbH | BSB |
| Jul 1, 1999 | K984640 | THERMAL ANGEL Estill Medical Technologies, Inc. | BSB |
| Apr 30, 1998 | K973741 | BAIR HUGGER BLOOD/FLUID WARMER Augustine Medical, Inc. | BSB |
| Jun 26, 1996 | K953741 | THERMACYL BLOOD/FLUID WARMER Baxter Healthcare Corp | BSB |
| Feb 14, 1977 | K770232 | BLOOD/FLUID WARMER MODEL DW-1000A Gorman Rupp Industries | BSB |
| Jul 16, 1976 | K760012 | BLOOD WARMER (CODE 4R4305) Travenol Laboratories, S.A. | BSB |
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