Atom Medical Corporation
Medical device manufacturer in Bonita Springs, FL.
15510(k) clearances
0PMA approvals
5recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K123937 | Atom Transcapsule V-707FPL · Traditional | 05/23/2013SE |
| K120937 | Sunflower WarnerFMT · Traditional | 07/06/2012SE |
| K111547 | Bili-Therapy Pad TypeLBI · Traditional | 04/12/2012SE |
| K103317 | Resuscitation Unit 105BZR · Traditional | 04/20/2011SE |
| K102542 | Resusci Flow; Resusci Flow 104BTL · Traditional | 04/06/2011SE |
| K103828 | Bili-Therapy Spot TypeLBI · Traditional | 03/29/2011SE |
| K102227 | Infa Warmer IFMT · Traditional | 01/21/2011SE |
| K102226 | Dual Incu IFMZ · Traditional | 01/04/2011SE |
| K102279 | Incu IFMZ · Traditional | 12/29/2010SE |
| K102710 | Neo-Servo IFMZ · Traditional | 12/22/2010SE |
| K061856 | V-2200 Infant IncubatorFMZ · Traditional | 09/28/2006SE |
| K061071 | V-808 Atom TranscapsuleFPL · Traditional | 08/29/2006SE |
| K060461 | V-505 Infa WarmerFMT · Special | 04/28/2006SE |
| K021809 | V-2100G Advanced Infant IncubatorFMZ · Abbreviated | 07/18/2002SE |
| K002355 | Atom Infa Warmer V-505FMT · Abbreviated | 10/10/2000SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1945-2012 Class II | Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo…There is a potential for the device's canopy to move unintentionally when using the incubator mode or… | 05/01/2012Terminated |
| Z-0340-2012 | Infa Warmer i (Atom Infant Warmer Model 103) Atom Medical Corporation 3-18-15 Hongo…The caster with lock on the radiant-warming open type incubator may become loose or break. | 08/23/2011Terminated |
| Z-0339-2012 | Rabee Incu i (Atom Infant Incubator Model 102) Atom Medical Corporation 3-18-15 Hongo…The caster with lock on the incubator may become loose or break. | 08/23/2011Terminated |
| Z-0338-2012 | Incu i (Atom Infant Incubator Model 101) Atom Medical Corporation 3-18-15 Hongo…The caster with lock on the incubator may become loose or break. | 08/23/2011Terminated |
| Z-0337-2012 | Dual Incu i (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo…The caster with lock on the incubator or infant warmer may become loose or break. | 08/23/2011Terminated |