ClearanceBrief
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

CodeDeviceRecords
LROGeneral Surgery Tray139
FSYLight, Surgical, Ceiling Mounted77
LHCWarmer, Irrigation Solution8
JOJIndicator, Physical/Chemical Sterilization Process1
LRSI.V. Start Kit1
OFFCentral Venous Catheter Tray1
PEZCentral Venous Catheter Dressing Change Kit1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 28, 2022Resource Optimization & Innovation LLC
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Terminated
LRSNone listed
Jun 17, 2020Resource 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
JOJK982188
May 4, 2020Resource 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
PEZNone listed
May 4, 2020Resource 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
OFFNone listed
Sep 25, 2017Resource Optimization & Innovation Llc
Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
Open, Classified
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa Rosa
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800413004, Sterile, CV0482D- Vascular PK - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800408003, Sterile, LD0477C - C-Section PK - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800408002, Sterile, LD0477B - C-Section PK - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800407004, Sterile, OR0476D - Ortho PK - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800401001, Sterile, GS0470A - Lap PK - Spohn
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800623001, Sterile, NU0787A - Neuro - Medical Center Santa Rosa
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland
Terminated
LRONone listed
Jan 9, 2017Resource Optimization & Innovation Llc
Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B - Medical Center Santa Rosa
Terminated
LRONone listed

Newest 50 of 228.

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