Company ยท US
Atom Medical Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2013. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 23, 2013 | K123937 | ATOM TRANSCAPSULE V-707 Atom Medical Corporation | FPL |
| Jul 6, 2012 | K120937 | SUNFLOWER WARNER Atom Medical Corporation | FMT |
| Apr 12, 2012 | K111547 | BILI-THERAPY PAD TYPE Atom Medical Corporation | LBI |
| Apr 20, 2011 | K103317 | RESUSCITATION UNIT 105 Atom Medical Corporation | BZR |
| Apr 6, 2011 | K102542 | RESUSCI FLOW; RESUSCI FLOW 104 Atom Medical Corporation | BTL |
| Mar 29, 2011 | K103828 | BILI-THERAPY SPOT TYPE Atom Medical Corporation | LBI |
| Jan 21, 2011 | K102227 | INFA WARMER I Atom Medical Corporation, JP | FMT |
| Jan 4, 2011 | K102226 | DUAL INCU I Atom Medical Corporation, JP | FMZ |
| Dec 29, 2010 | K102279 | INCU I Atom Medical Corporation, JP | FMZ |
| Dec 22, 2010 | K102710 | NEO-SERVO I Atom Medical Corporation | FMZ |
| Sep 28, 2006 | K061856 | V-2200 INFANT INCUBATOR Atom Medical, Inc. | FMZ |
| Aug 29, 2006 | K061071 | V-808 ATOM TRANSCAPSULE Atom Medical, Inc. | FPL |
| Apr 28, 2006 | K060461 | V-505 INFA WARMER Atom Medical, Inc., JP | FMT |
| Jul 18, 2002 | K021809 | V-2100G ADVANCED INFANT INCUBATOR Atom Medical Corp | FMZ |
| Oct 10, 2000 | K002355 | ATOM INFA WARMER V-505 Atom Medical Corp | FMT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2012 | Atom Medical Corporation Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants. Terminated |
FMZ | K102226 |
| Dec 1, 2011 | Atom Medical Corporation Infa Warmer i (Atom Infant Warmer Model 103)
Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033
Usage: A warmer for infants. Terminated |
FMZ | K102226 |
| Dec 1, 2011 | Atom Medical Corporation Rabee Incu i (Atom Infant Incubator Model 102)
Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033
Usage: An incubator for infants. Terminated |
FMZ | K102226 |
| Dec 1, 2011 | Atom Medical Corporation Incu i (Atom Infant Incubator Model 101)
Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033
Usage: An incubator for infants. Terminated |
FMZ | K102226 |
| Dec 1, 2011 | Atom Medical Corporation Dual Incu i (Atom Infant Incubator Model 100)
Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033
Usage: A combination incubator and warmer for infants. Terminated |
FMZ | K102226 |