Panels › General Hospital › Product code MRZ · Class 2
Accessories, Pump, Infusion
Regulation 880.5725
0510(k)s in 12 months (48 all time)
0recalls in 12 months (8 all time)
7recalls that name a 510(k)
Top companies in MRZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Alexander Mfg. Co. | 8 | 0 |
| Welldoc, Inc. | 8 | 0 |
| Icu Medical | 1 | 6 |
| National Custom Ent., Inc. | 3 | 0 |
| Smiths Medical MD, Inc. | 3 | 0 |
| Aidera AB | 2 | 0 |
| Animas Corp. | 1 | 1 |
| American I.V. Products, Inc. | 1 | 0 |
| American I.V. Products, Inc. Dba Aiv, Inc. | 1 | 0 |
| Appro Healthcare, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2024 | Smiths Medical ASD Inc. Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716 Open, Classified |
MRZ | K111386 |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, Terminated |
MRZ | K171346 |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 3 Terminated |
MRZ | None listed |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 M Terminated |
MRZ | K141789 |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 Inch. 1 unit per Terminated |
MRZ | K171346 |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tu Terminated |
MRZ | K141789 |
| Nov 8, 2018 | ICU Medical Inc SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02
Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's Terminated |
MRZ | K171346 |
| Dec 3, 2009 | Animas Corporation Animas ezManager Max Diabetes Management System version 2.0.9 Terminated |
MRZ | K080587 |
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