Panels › Physical Medicine › Product code LHC · Class 1
Warmer, Irrigation Solution
Regulation 890.5950
0510(k)s in 12 months (24 all time)
0recalls in 12 months (10 all time)
9recalls that name a 510(k)
Top companies in LHC
| Company | 510(k)s | Recalls |
|---|---|---|
| Resource Optimization & Innovation Llc | 0 | 8 |
| Ecolab, Inc. | 4 | 1 |
| O.R. Solutions, Inc. | 4 | 0 |
| C Change Surgical, LLC | 2 | 0 |
| American Hydro-Surgical Instruments, Inc. | 1 | 0 |
| Augustine Medical, Inc. | 1 | 0 |
| Cabot Medical Corp. | 1 | 0 |
| Getinge Sourcing, LLC | 1 | 0 |
| Johnson Flexgroup | 1 | 0 |
| Kmi Kolster Methods, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2017 | Smiths Medical ASD, Inc. NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230.
Product Usage:
NORMOFLO H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming Terminated |
LHC | None listed |
| Oct 30, 2015 | Resource Optimization & Innovation Llc Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery. Terminated |
LHC | K142080 |
| Oct 30, 2015 | Resource Optimization & Innovation Llc Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery. Terminated |
LHC | K142080 |
| Oct 30, 2015 | Resource Optimization & Innovation Llc Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery. Terminated |
LHC | K142080 |
| Oct 30, 2015 | Resource Optimization & Innovation Llc Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery. Terminated |
LHC | K142080 |
| Oct 30, 2015 | Resource Optimization & Innovation Llc Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery. Terminated |
LHC | K142080 |
| Oct 30, 2015 | Resource Optimization & Innovation Llc Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery. Terminated |
LHC | K142080 |
| Oct 30, 2015 | Resource Optimization & Innovation Llc Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery. Terminated |
LHC | K142080 |
| Oct 30, 2015 | Resource Optimization & Innovation Llc Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery. Terminated |
LHC | K142080 |
| Sep 18, 2015 | Ecolab Inc Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331
and ORS-2200.
The ORS Fluid Warming and Terminated |
LHC | K021288 K023282 +1 |
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