International Biomedical, Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 17
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1531-2013 | Class II | VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with t | May 24, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K221154 | Infant Heel WarmerTM; Heel Snuggler® | October 7, 2022 |
| K221653 | InfaTherm Disposable Infant Warming Mattress | October 6, 2022 |
| K220742 | NxtGen Infant Transport Incubator | July 15, 2022 |
| K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | March 10, 2020 |
| K182956 | Puffin Lite Infant Resuscitation System | January 18, 2019 |
| K173516 | NuBorne Infant Warmer | August 17, 2018 |
| K160238 | Airborne Phototherapy Light | June 14, 2016 |
| K140707 | LIFEBORNE INFANT RESUSCITATOR | May 28, 2014 |
| K103525 | A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX | May 11, 2011 |
| K103523 | 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | May 11, 2011 |
| K103524 | VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | April 15, 2011 |
| K103527 | AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | April 15, 2011 |
| K093260 | AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM | December 16, 2009 |
| K081399 | AVIATOR TRANSPORT INCUBATOR | June 6, 2008 |
| K022873 | POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK) | March 21, 2003 |
| K022876 | MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 | September 11, 2002 |
| K955766 | ADULT-PEDIATRIC TRANSPORT SYSTEM | August 7, 1996 |