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 |
|---|---|---|---|
| Jan 17, 2025 | K243606 | Babyroo TN300 Draeger Medical Systems, Inc. | FMT |
| May 30, 2023 | K230278 | Babyroo TN300 Draeger Medical Systems, Inc. | FMT |
| Mar 2, 2022 | K213551 | Giraffe Omnibed Carestation CS1 Datex Ohmeda, Inc. | FMT |
| Feb 12, 2021 | K201628 | Panda iRes Warmer, Giraffe Warmer GE Healthcare | FMT |
| Apr 2, 2020 | K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Deroyal Industries, Inc. | FMT |
| Jan 21, 2020 | K191425 | Hydro-Temp Neonatal Skin Temperature Probe Cover Deroyal Industries, Inc. | FMT |
| Aug 17, 2018 | K173516 | NuBorne Infant Warmer International Biomedical | FMT |
| Feb 5, 2013 | K123309 | GIRAFFE AND PANDA WARMERS Ohmeda Medical | FMT |
| Nov 2, 2012 | K120642 | RESUSCITAIRE WITH AUTOBREATH Draeger Medical Systems, Inc. | FMT |
| Oct 2, 2012 | K122267 | GIRAFFE AND PANDA WARMERS Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | FMT |
| Sep 14, 2012 | K121625 | LULLABY TM WARMER Wipro GE Healthcare Private, Ltd. | FMT |
| Jul 6, 2012 | K120937 | SUNFLOWER WARNER Atom Medical Corporation | FMT |
| Jan 21, 2011 | K102227 | INFA WARMER I Atom Medical Corporation, JP | FMT |
| Jul 21, 2010 | K101804 | GIRAFFE AND PANDA WARMERS Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | FMT |
| Apr 16, 2009 | K090697 | MODIFICATION TO: GIRAFFE AND PANDA WARMER Ohmeda Medical | FMT |
| Aug 27, 2007 | K072157 | MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) Ohmeda Medical | FMT |
| Jul 11, 2007 | K070377 | GIRAFFE AND PANDA WARMER Ohmeda Medical | FMT |
| Apr 28, 2006 | K060461 | V-505 INFA WARMER Atom Medical, Inc., JP | FMT |
| Dec 17, 2003 | K033040 | PHOENIX INFANT RADIANT WARMER, MODEL 100NWS International Hospital Supply Co., NL | FMT |
| Jun 13, 2002 | K020966 | RPI REPLACEMENT HEATING ELEMENTS Replacement Parts Industries, Inc. | FMT |
| Apr 12, 2002 | K020219 | RPI SKIN OR AIR TEMPERATURE PROBE Replacement Parts Industries, Inc. | FMT |
| Sep 10, 2001 | K012229 | SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC National Custom Ent., Inc. | FMT |
| Nov 17, 2000 | K003335 | RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER Hill-Rom Air-Shields | FMT |
| Oct 10, 2000 | K002355 | ATOM INFA WARMER V-505 Atom Medical Corp | FMT |
| Jan 5, 1998 | K971366 | INCUWARMER Hill-Rom, Inc. | FMT |
| Oct 30, 1997 | K972885 | SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970 Fisher & Paykel Electronics , Ltd., NZ | FMT |
| Oct 3, 1997 | K971198 | BABYTHERM 8004 BABYTHERM 8010 Drager, Inc. | FMT |
| Aug 25, 1997 | K970686 | ACCUTEMP-PROBE Kentec Medical, Inc. | FMT |
| Jul 28, 1997 | K971695 | SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER Fisher & Paykel Electronics , Ltd., NZ | FMT |
| Jul 16, 1997 | K971461 | SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990) Fisher & Paykel Electronics , Ltd., NZ | FMT |
| May 7, 1997 | K970432 | INFANT RADIANT WARMER - MODELS IW910 AND IW920 Fisher & Paykel Electronics , Ltd., NZ | FMT |
| Apr 3, 1997 | K970074 | STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) Hill-Rom, Inc. | FMT |
| Feb 6, 1997 | K964401 | KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4) Ludlow Technical Products | FMT |
| Jan 23, 1997 | K950422 | FIRST TOUCH DISPOSABLES TEMPERATURE PROBES First Touch Disposables, Inc. | FMT |
| Oct 1, 1996 | K963058 | INFANT WARMER SYSTEM Ohmeda Medical | FMT |
| May 1, 1996 | K960080 | ACCUTEMP PROBE Kentec Medical, Inc. | FMT |
| Apr 4, 1996 | K952807 | TEMPERATURE PROBE-TP650 Contour Medical Technology, Inc. | FMT |
| Apr 4, 1996 | K952805 | TEMPERATURE PROBE-TP550 Contour Medical Technology, Inc. | FMT |
| Apr 4, 1996 | K952804 | TEMPERATURE PROBE-TP450 Contour Medical Technology, Inc. | FMT |
| Apr 4, 1996 | K952803 | TEMPERATURE PROBE-TP350 Contour Medical Technology, Inc. | FMT |
| Apr 4, 1996 | K952801 | TEMPERATURE PROBE-TP250 Contour Medical Technology, Inc. | FMT |
| Apr 4, 1996 | K952800 | TEMPERATURE PROBE-TP150 Contour Medical Technology, Inc. | FMT |
| Feb 9, 1996 | K953489 | DRAGER INFANT RADIANT WARMERN RH600 Drager, Inc. | FMT |
| Sep 25, 1995 | K950143 | ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE Astral, Ltd. | FMT |
| Sep 25, 1995 | K946005 | ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE Astral, Ltd. | FMT |
| May 3, 1995 | K940951 | RW RESUCITAIRE INFANT RADIANT WARMER Air-Shields, Inc. | FMT |
| Feb 27, 1995 | K942905 | DISPOSABLE TEMPERATURE PROBE COVER Arbo Medical, Inc. | FMT |
| Sep 16, 1994 | K942904 | STABILET Hill-Rom, Inc. | FMT |
| Jul 5, 1994 | K934677 | U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE U.S. Medical Corp. | FMT |
| Jul 1, 1994 | K935609 | 4002 INFANT SCALE FOR INCUBATORS AND WARMERS Scale-Tronix, Inc. | FMT |
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