Panels › General Hospital › Product code FMT · Class 2
Warmer, Infant Radiant
Regulation 880.5130
0510(k)s in 12 months (92 all time)
2recalls in 12 months (36 all time)
34recalls that name a 510(k)
Top companies in FMT
| Company | 510(k)s | Recalls |
|---|---|---|
| GE Healthcare | 1 | 19 |
| Ohmeda Medical | 10 | 5 |
| Contour Medical Technology, Inc. | 6 | 0 |
| Draeger Medical Systems, Inc. | 3 | 3 |
| Air-Shields, Inc. | 5 | 0 |
| Atom Medical Corp | 4 | 0 |
| Deroyal Industries, Inc. | 3 | 1 |
| Fisher & Paykel Electronics , Ltd. | 4 | 0 |
| Gempco, Inc. | 4 | 0 |
| Hill-Rom, Inc. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 11, 1994 | K931529 | INFANT WARMER Medix I.C.S.A., AR | FMT |
| Feb 24, 1994 | K926030 | KLEAR-TEMP Cas Medical Systems, Inc. | FMT |
| Jan 31, 1994 | K925006 | HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO Deroyal Industries, Inc. | FMT |
| Jul 23, 1993 | K921547 | ADVANTAGE Kci | FMT |
| Apr 23, 1993 | K921766 | OHIO INFANT WARMER SYSTEM Ohmeda Medical | FMT |
| Oct 30, 1992 | K912921 | VSI 1000 Vitaltrends Technology, Inc. | FMT |
| Jun 8, 1992 | K915831 | THERMAL PROBE COVER Vermont Medical, Inc. | FMT |
| Feb 12, 1992 | K913945 | STABILET INFANT RADIANT WARMER MODEL 2000C Hill-Rom, Inc. | FMT |
| Jul 16, 1991 | K910915 | PATIENT WARMER MODEL 100C Developmed Corp. | FMT |
| Aug 7, 1989 | K885350 | PREEMICARE SERIES 2000 INFANT WARMER Preemicare Corp. | FMT |
| Dec 22, 1988 | K884285 | MODEL WC-115 MOBILE BASSINET Gempco, Inc. | FMT |
| Dec 22, 1988 | K884283 | MODEL WC-107 MOBILE NEWBORN BED Gempco, Inc. | FMT |
| Dec 22, 1988 | K884280 | MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET Gempco, Inc. | FMT |
| Nov 22, 1988 | K881670 | ACCUTEMP PLUS Sentry Medical Products, Inc. | FMT |
| Nov 21, 1988 | K884160 | OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM Ohmeda Medical | FMT |
| Jul 12, 1988 | K881713 | SPECIAL PROCEDURES BASE UNIT MODEL 500 Gempco, Inc. | FMT |
| Jan 19, 1988 | K875270 | INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS Air-Shields, Inc. | FMT |
| Oct 20, 1987 | K872742 | WARM WEIGH MODELS I-20/W-30 INFANT SCALE Air-Shields, Inc. | FMT |
| Oct 9, 1987 | K871178 | MTC XI UL Aragona Medical, Inc. | FMT |
| Oct 9, 1987 | K871177 | NTH 101 UL Aragona Medical, Inc. | FMT |
| Jun 5, 1987 | K871594 | BIRTHING ROOM WARMER Air-Shields, Inc. | FMT |
| Apr 1, 1987 | K862921 | MODEL 10200 PREMATURE INFANT INCUBATOR Rotem Industries C/O Medsys, Inc. | FMT |
| Mar 4, 1987 | K865012 | YSI MODEL 801 Yellow Springs Instrument Co., Inc. | FMT |
| Oct 3, 1986 | K863208 | OHMEDA AUXILIARY POWER SYSTEM Ohmeda Medical | FMT |
| Jul 15, 1986 | K861781 | DELIVERY ROOM WARMER Air-Shields, Inc. | FMT |
| Feb 26, 1986 | K853926 | NEOCARE MODEL 800 INFANT RADIANT WARMER Draeger Medical, Inc. | FMT |
| Nov 8, 1985 | K852943 | NEO SHIELD Gaymar Industries, Inc. | FMT |
| Oct 17, 1985 | K853351 | OHMEDA HEAT REFLECTING PATCH Ohmeda Medical | FMT |
| Oct 16, 1985 | K853794 | NEOGUARD REFLECTOR Cas Medical Systems, Inc. | FMT |
| Jun 7, 1985 | K851449 | OHMEDA 5000 INFANT WARMER SYSTEM Ohmeda Medical | FMT |
| May 30, 1985 | K850069 | BORNING NEONATAL RESUSCITATOIN CENTER Borning Corp. | FMT |
| May 25, 1984 | K840792 | INFANT RADIANT WARMER Hatch Bio Medical | FMT |
| Apr 5, 1984 | K833802 | INFANT WARMER Kinetic Concepts, Inc. | FMT |
| Mar 23, 1984 | K840858 | OHIO 3300 INFANT WARMER SYSTEM Ohio Medical Products | FMT |
| Mar 23, 1984 | K840857 | OHIO 3000 INFANT WARMER SYSTEM Ohio Medical Products | FMT |
| Dec 22, 1983 | K832637 | AMEDA NEONATAL RESUSCITATION UNIT- Egnell, Inc. | FMT |
| Jun 22, 1983 | K830748 | RESUSCITAIRE Vickers America Medical Corp. | FMT |
| Jan 25, 1982 | K813408 | SAGE 2200 STERILE SPECIMEN CONTAINER Sage Products, Inc. | FMT |
| Nov 2, 1981 | K812745 | WARMING LISTHTS #96H & 96HT J. H. Emerson Co. | FMT |
| Oct 23, 1980 | K802365 | OHIO RADIANT WARMER Ohio Medical Products | FMT |
| Sep 24, 1979 | K790948 | TEMP-GUARD TM Gordon Consultants, Inc. | FMT |
| Mar 6, 1979 | K790137 | INFANT CARE SYSTEM Narco Air-Shields | FMT |
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