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
| Code | Device | Records |
|---|---|---|
| OJH | Orthopedic Tray | 18 |
| OJG | Neurological Tray | 14 |
| MLS | Labor And Delivery Kit | 9 |
| OJK | Eye Tray | 8 |
| LRO | General Surgery Tray | 6 |
| OEZ | Cardiovascular Procedure Kit | 6 |
| FDE | Laparoscopy Kit | 4 |
| OGR | Ear, Nose, And Throat Surgical Tray | 3 |
| OHM | Cesarean Section Tray | 3 |
| LRS | I.V. Start Kit | 2 |
| OIP | Radiology-Diagnostic Kit | 2 |
| OXQ | Dressing Change Tray | 2 |
| EFQ | Gauze/Sponge, Internal | 1 |
| FTN | Plastic Surgery And Accessories Kit | 1 |
| KPE | Container, I.V. | 1 |
| OEA | Non-Surgical Gown | 1 |
| OEQ | Angiography/Angioplasty Kit | 1 |
| OES | Cardiac Catheterization Kit | 1 |
| OEV | Cardiopulmonary Resuscitation Aid Kit | 1 |
| OHD | Gynecological Laparoscopic Kit | 1 |
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 4, 2025 | ROi 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 |
MLS | None listed |
| Sep 17, 2024 | ROi CPS LLC regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009 Open, Classified |
OEQ | None listed |
| Aug 16, 2024 | ROi CPS LLC Regard Kit containing the Microtek decanter Open, Classified |
KPE | None listed |
| Jan 12, 2024 | ROi CPS LLC regard Operative LAP, Item Number 800943001; surgical convenience kit Terminated |
LRO | None listed |
| Jan 3, 2024 | ROi CPS LLC Regard Dressing change kit, Item Number 800026006 Terminated |
OXQ | None listed |
| Nov 16, 2023 | ROi CPS LLC Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit Open, Classified |
OEZ | None listed |
| Oct 6, 2023 | ROi CPS LLC GS0008 2Y - Burn Pack - STL, Item Number 880082025 Open, Classified |
OJJ | None listed |
| Apr 25, 2023 | ROi 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 |
OJH | None listed |
| Apr 25, 2023 | ROi 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 |
OJG | None listed |
| Apr 25, 2023 | ROi CPS LLC Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack. Open, Classified |
OHM | None listed |
| Apr 25, 2023 | ROi CPS LLC Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack. Open, Classified |
OHD | None listed |
| Apr 25, 2023 | ROi CPS LLC Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath. Open, Classified |
OES | None listed |
| Apr 25, 2023 | ROi CPS LLC Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack. Open, Classified |
MLS | None listed |
| Apr 25, 2023 | ROi 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 |
LRO | None listed |
| Apr 25, 2023 | ROi CPS LLC Sterile surgical convenience kits:
1. regard Item Number: 880405003, GS01011C - General Laparoscopy;
2. regard Item Number: 880424004, GS01031D - Thoracic. Open, Classified |
FDE | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit Terminated |
FDE | None listed |
| Nov 23, 2022 | ROi CPS LLC regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit Terminated |
OJK | None listed |
| Nov 23, 2022 | ROi CPS LLC regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit Terminated |
OJK | None listed |
| Nov 23, 2022 | ROi CPS LLC regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit Terminated |
LRO | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit Terminated |
FDE | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit Terminated |
OJK | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard CVPART1BUNDLE- MERCYSTANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit Terminated |
OEZ | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit Terminated |
OJK | None listed |
| Nov 23, 2022 | ROi CPS LLC regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit Terminated |
OJK | None listed |
| Nov 23, 2022 | ROi CPS LLC regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit Terminated |
OGR | None listed |
| Nov 23, 2022 | ROi CPS LLC regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit Terminated |
OJG | None listed |
| Nov 23, 2022 | ROi CPS LLC regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit Terminated |
OJK | None listed |
| Nov 23, 2022 | ROi CPS LLC regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit Terminated |
OJH | None listed |
| Nov 23, 2022 | ROi CPS LLC regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit Terminated |
OJG | None listed |
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