Panels › General Hospital › Product code LGZ · Class 2
Warmer, Thermal, Infusion Fluid
Regulation 880.5725
3510(k)s in 12 months (76 all time)
1recalls in 12 months (33 all time)
31recalls that name a 510(k)
Top companies in LGZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Smiths Medical Asd, Inc. | 1 | 13 |
| Belmont Instrument Corp. | 6 | 4 |
| Quality IN Flow , Ltd. | 5 | 0 |
| Smisson-Cartledge Biomedical, LLC | 2 | 3 |
| Rand S.R.L. | 2 | 2 |
| STERIS Corporation | 3 | 1 |
| C.F. Electronics, Inc. | 3 | 0 |
| Medical Solutions, Inc. | 3 | 0 |
| Arizant Healthcare, Inc. | 2 | 0 |
| Automatic Medical Technologies, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 16, 2003 | K032674 | BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 Belmont Instrument Corp. | LGZ |
| Jul 23, 2003 | K031390 | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712 Minimed, Inc. | LGZ |
| Jan 28, 2003 | K024373 | MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5 Elltec Co., Ltd., JP | LGZ |
| Jan 17, 2003 | K023653 | MAXONE IV FLUID/BLOOD WARMER, MODEL 102 Automatic Medical Technologies, Inc. | LGZ |
| Oct 24, 2001 | K012832 | COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 Nxstage Medical, Inc. | LGZ |
| Oct 9, 2001 | K012906 | ANIMEC, MODELS AM-2S-4 AND AM-2S-5 Elltec Co., Ltd., JP | LGZ |
| Aug 20, 2001 | K012276 | TEMP 3 Medical Solutions, Inc. | LGZ |
| Jun 28, 2001 | K002409 | MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER Automatic Medical Technologies, Inc. | LGZ |
| Aug 9, 2000 | K001764 | HOTLINE 2 FLUID WARMER Sims Level 1, Inc. | LGZ |
| Jul 10, 1998 | K981509 | TEMPO III Medical Products, Inc. | LGZ |
| Mar 10, 1998 | K980086 | HEAT STACK Medical Solutions, Inc. | LGZ |
| Mar 10, 1998 | K973748 | TEMPO AND TEMP H20 Smith | LGZ |
| Aug 8, 1996 | K954769 | BIEGLER BW385L BLOOD & INFUSION WARMER Biegler Medical Products, Inc., CA | LGZ |
| May 14, 1996 | K955659 | DRUGBOX C.F. Electronics, Inc. | LGZ |
| Jan 27, 1993 | K922786 | THERM O DRUG MODEL HT-747 C.F. Electronics, Inc. | LGZ |
| Oct 23, 1992 | K914867 | QWIK-1(TM) IN-LINE IV FLUID WARMER Microwave Medical Systems, Inc. | LGZ |
| Sep 10, 1992 | K914364 | ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO. North American Technical Services Corp. | LGZ |
| Sep 2, 1992 | K921395 | HOT SACK C.F. Electronics, Inc. | LGZ |
| Oct 17, 1991 | K911383 | HOTLINE FLUID WARMER Level 1 Technologies, Inc. | LGZ |
| Oct 15, 1990 | K904252 | HEATWAVE Medadvances, Inc. | LGZ |
| Feb 9, 1990 | K896018 | BIOTEMP Medadvances, Inc. | LGZ |
| Feb 28, 1989 | K883873 | INFUSION FLUID WARMER Pmt Corp. | LGZ |
| Aug 25, 1988 | K882361 | STIHLER ASTOTHERM IFT 200, IFT 220 Stihler Electronic, C/O Worldwide Regul. Services | LGZ |
| Aug 20, 1982 | K822098 | BT 794-BLOOD/FLUID WARMER Electromedics, Inc. | LGZ |
| Dec 9, 1981 | K813161 | FLO TEM II (BLOOD/FLUID WARMER Datachem, Inc. | LGZ |
| May 21, 1981 | K803249 | FLUID WARMER Datachem, Inc. | LGZ |
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