Company
Resource Optimization & Innovation 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)
228recalls (0 in 12 months)
9recalls 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) |
|---|---|---|---|
| Feb 28, 2022 | Resource Optimization & Innovation LLC Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site Terminated |
LRS | None listed |
| Jun 17, 2020 | Resource Optimization & Innovation LLC regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of s Terminated |
JOJ | K982188 |
| May 4, 2020 | Resource Optimization & Innovation LLC Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices. Terminated |
PEZ | None listed |
| May 4, 2020 | Resource Optimization & Innovation LLC Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices. Terminated |
OFF | None listed |
| Sep 25, 2017 | Resource Optimization & Innovation Llc Regard Custom Surgical Pack
Packs contain surgical instruments and accessories intended for use during a surgical procedure. Open, Classified |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa Rosa Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800413004, Sterile, CV0482D- Vascular PK - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800408003, Sterile, LD0477C - C-Section PK - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800408002, Sterile, LD0477B - C-Section PK - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800407004, Sterile, OR0476D - Ortho PK - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800401001, Sterile, GS0470A - Lap PK - Spohn Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800623001, Sterile, NU0787A - Neuro - Medical Center Santa Rosa Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland Terminated |
LRO | None listed |
| Jan 9, 2017 | Resource Optimization & Innovation Llc Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B - Medical Center Santa Rosa Terminated |
LRO | None listed |
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