Company · US
International Biomedical
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2022. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FPL | Incubator, Neonatal Transport | 7 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 2 |
| MRN | Apparatus, Nitric Oxide Delivery | 2 |
| FMT | Warmer, Infant Radiant | 1 |
| FPO | Stretcher, Wheeled | 1 |
| IMD | Pack, Hot Or Cold, Disposable | 1 |
| KGO | Surgeon'S Gloves | 1 |
| LBI | Unit, Neonatal Phototherapy | 1 |
| LZF | Pump, Infusion, Analytical Sampling | 1 |
| MPO | Infant Heel Warmer (Chemical Heat Pack) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 7, 2022 | K221154 | Infant Heel WarmerTM; Heel Snuggler® International Biomedical | MPO |
| Oct 6, 2022 | K221653 | InfaTherm Disposable Infant Warming Mattress International Biomedical | IMD |
| Jul 15, 2022 | K220742 | NxtGen Infant Transport Incubator International Biomedical | FPL |
| Mar 10, 2020 | K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System International Biomedical | MRN |
| Jan 18, 2019 | K182956 | Puffin Lite Infant Resuscitation System International Biomedical | BTL |
| Aug 17, 2018 | K173516 | NuBorne Infant Warmer International Biomedical | FMT |
| Jun 14, 2016 | K160238 | Airborne Phototherapy Light International Biomedical | LBI |
| May 28, 2014 | K140707 | LIFEBORNE INFANT RESUSCITATOR International Biomedical | BTL |
| May 11, 2011 | K103525 | A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX International Biomedical, Ltd. | FPL |
| May 11, 2011 | K103523 | 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX International Biomedical, Ltd. | FPL |
| Apr 15, 2011 | K103527 | AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX International Biomedical, Ltd. | FPL |
| Apr 15, 2011 | K103524 | VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX International Biomedical, Ltd. | FPL |
| Dec 16, 2009 | K093260 | AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM International Biomedical, Ltd. | MRN |
| Jun 6, 2008 | K081399 | AVIATOR TRANSPORT INCUBATOR International Biomedical, Ltd. | FPL |
| Mar 21, 2003 | K022873 | POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK) International Biomedical, Inc. | KGO |
| Sep 11, 2002 | K022876 | MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 International Biomedical, Inc. | FPL |
| Aug 7, 1996 | K955766 | ADULT-PEDIATRIC TRANSPORT SYSTEM International Biomedical, Inc. | FPO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2013 | International Biomedical, Ltd. VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The collection bag is packaged in a tyvek pou Terminated |
LZF | K922997 |