Company
Sun Med, LLC
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
15recalls (0 in 12 months)
14recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126P Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126FP Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126FL Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126F Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126C Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126 Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116PD5 Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116PC Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116P Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116FC Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1116F Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116 Terminated |
BTM | K953546 |
| May 24, 2018 | Sun Med, LLC STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1 Terminated |
BTM | K953546 |
| Dec 24, 2008 | Sun Med, Inc. Sun Med GreenLine/D Laryngoscope Blades Compatible with Fiber Optic Green System Handles, Sterile Disposable. Contents 20. Terminated |
CCW | None listed |