ClearanceBrief
Company

ROi CPS 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)
86recalls (0 in 12 months)
2recalls that name a 510(k)

Product codes

CodeDeviceRecords
OJHOrthopedic Tray18
OJGNeurological Tray14
MLSLabor And Delivery Kit9
OJKEye Tray8
LROGeneral Surgery Tray6
OEZCardiovascular Procedure Kit6
FDELaparoscopy Kit4
OGREar, Nose, And Throat Surgical Tray3
OHMCesarean Section Tray3
LRSI.V. Start Kit2
OIPRadiology-Diagnostic Kit2
OXQDressing Change Tray2
EFQGauze/Sponge, Internal1
FTNPlastic Surgery And Accessories Kit1
KPEContainer, I.V.1
OEANon-Surgical Gown1
OEQAngiography/Angioplasty Kit1
OESCardiac Catheterization Kit1
OEVCardiopulmonary Resuscitation Aid Kit1
OHDGynecological Laparoscopic Kit1

Latest 510(k) clearances

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

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 4, 2025ROi CPS LLC
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
Open, Classified
MLSNone listed
Sep 17, 2024ROi CPS LLC
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Open, Classified
OEQNone listed
Aug 16, 2024ROi CPS LLC
Regard Kit containing the Microtek decanter
Open, Classified
KPENone listed
Jan 12, 2024ROi CPS LLC
regard Operative LAP, Item Number 800943001; surgical convenience kit
Terminated
LRONone listed
Jan 3, 2024ROi CPS LLC
Regard Dressing change kit, Item Number 800026006
Terminated
OXQNone listed
Nov 16, 2023ROi CPS LLC
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Open, Classified
OEZNone listed
Oct 6, 2023ROi CPS LLC
GS0008 2Y - Burn Pack - STL, Item Number 880082025
Open, Classified
OJJNone listed
Apr 25, 2023ROi CPS LLC
Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, O
Open, Classified
OJHNone listed
Apr 25, 2023ROi CPS LLC
Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number
Open, Classified
OJGNone listed
Apr 25, 2023ROi CPS LLC
Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
Open, Classified
OHMNone listed
Apr 25, 2023ROi CPS LLC
Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
Open, Classified
OHDNone listed
Apr 25, 2023ROi CPS LLC
Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
Open, Classified
OESNone listed
Apr 25, 2023ROi CPS LLC
Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.
Open, Classified
MLSNone listed
Apr 25, 2023ROi CPS LLC
Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004,
Open, Classified
LRONone listed
Apr 25, 2023ROi CPS LLC
Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
Open, Classified
FDENone listed
Nov 23, 2022ROi CPS LLC
regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit
Terminated
FDENone listed
Nov 23, 2022ROi CPS LLC
regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit
Terminated
OJKNone listed
Nov 23, 2022ROi CPS LLC
regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit
Terminated
OJKNone listed
Nov 23, 2022ROi CPS LLC
regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit
Terminated
LRONone listed
Nov 23, 2022ROi CPS LLC
regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit
Terminated
OJGNone listed
Nov 23, 2022ROi CPS LLC
regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kit
Terminated
OJGNone listed
Nov 23, 2022ROi CPS LLC
regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit
Terminated
OJGNone listed
Nov 23, 2022ROi CPS LLC
regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
Terminated
FDENone listed
Nov 23, 2022ROi CPS LLC
regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit
Terminated
OJKNone listed
Nov 23, 2022ROi CPS LLC
regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard CVPART1BUNDLE- MERCYSTANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit
Terminated
OEZNone listed
Nov 23, 2022ROi CPS LLC
regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit
Terminated
OJGNone listed
Nov 23, 2022ROi CPS LLC
regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit
Terminated
OJKNone listed
Nov 23, 2022ROi CPS LLC
regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit
Terminated
OJKNone listed
Nov 23, 2022ROi CPS LLC
regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit
Terminated
OJGNone listed
Nov 23, 2022ROi CPS LLC
regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit
Terminated
OJGNone listed
Nov 23, 2022ROi CPS LLC
regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit
Terminated
OJGNone listed
Nov 23, 2022ROi CPS LLC
regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit
Terminated
OJGNone listed
Nov 23, 2022ROi CPS LLC
regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit
Terminated
OGRNone listed
Nov 23, 2022ROi CPS LLC
regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit
Terminated
OJGNone listed
Nov 23, 2022ROi CPS LLC
regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit
Terminated
OJGNone listed
Nov 23, 2022ROi CPS LLC
regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit
Terminated
OJKNone listed
Nov 23, 2022ROi CPS LLC
regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit
Terminated
OJHNone listed
Nov 23, 2022ROi CPS LLC
regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit
Terminated
OJGNone listed

Newest 50 of 86.

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