Atlas FDA

ROi CPS LLC

63 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Res recall (Z-1047-2025)ROi CPS LLC2025-02-04
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009 recall (Z-3159-2024)ROi CPS LLC2024-09-17
Regard Kit containing the Microtek decanter recall (Z-2685-2024)ROi CPS LLC2024-08-16
regard Operative LAP, Item Number 800943001; surgical convenience kit recall (Z-0620-2024)ROi CPS LLC2024-01-12
Regard Dressing change kit, Item Number 800026006 recall (Z-0596-2024)ROi CPS LLC2024-01-03
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit recall (Z-0315-2024)ROi CPS LLC2023-11-16
GS0008 2Y - Burn Pack - STL, Item Number 880082025 recall (Z-0070-2024)ROi CPS LLC2023-10-06
Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General La recall (Z-1431-2023)ROi CPS LLC2023-04-25
Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy recall (Z-1432-2023)ROi CPS LLC2023-04-25
Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vagi recall (Z-1433-2023)ROi CPS LLC2023-04-25
Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath. recall (Z-1434-2023)ROi CPS LLC2023-04-25
Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparo recall (Z-1435-2023)ROi CPS LLC2023-04-25
Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pac recall (Z-1436-2023)ROi CPS LLC2023-04-25
Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminec recall (Z-1437-2023)ROi CPS LLC2023-04-25
Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shou recall (Z-1438-2023)ROi CPS LLC2023-04-25
regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit recall (Z-0283-2023)ROi CPS LLC2022-11-23
regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit recall (Z-0284-2023)ROi CPS LLC2022-11-23
regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit recall (Z-0285-2023)ROi CPS LLC2022-11-23
regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit recall (Z-0286-2023)ROi CPS LLC2022-11-23
regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit recall (Z-0287-2023)ROi CPS LLC2022-11-23
regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit recall (Z-0288-2023)ROi CPS LLC2022-11-23
regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit recall (Z-0289-2023)ROi CPS LLC2022-11-23
regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit recall (Z-0290-2023)ROi CPS LLC2022-11-23
regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit recall (Z-0291-2023)ROi CPS LLC2022-11-23
regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit recall (Z-0292-2023)ROi CPS LLC2022-11-23
regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit recall (Z-0293-2023)ROi CPS LLC2022-11-23
regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience ki recall (Z-0294-2023)ROi CPS LLC2022-11-23
regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit recall (Z-0295-2023)ROi CPS LLC2022-11-23
regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit recall (Z-0296-2023)ROi CPS LLC2022-11-23
regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit recall (Z-0297-2023)ROi CPS LLC2022-11-23
regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit recall (Z-0298-2023)ROi CPS LLC2022-11-23
regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit recall (Z-0299-2023)ROi CPS LLC2022-11-23
regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit recall (Z-0300-2023)ROi CPS LLC2022-11-23
regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit recall (Z-0301-2023)ROi CPS LLC2022-11-23
regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit recall (Z-0302-2023)ROi CPS LLC2022-11-23
regard CVPART1BUNDLE- MERCYSTANTHONY , CV01005H, Item Number 830099008; cardiac surgery co recall (Z-0303-2023)ROi CPS LLC2022-11-23
regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenie recall (Z-0304-2023)ROi CPS LLC2022-11-23
regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience ki recall (Z-0305-2023)ROi CPS LLC2022-11-23
regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit recall (Z-0306-2023)ROi CPS LLC2022-11-23
regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery conv recall (Z-0307-2023)ROi CPS LLC2022-11-23
regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kit recall (Z-0308-2023)ROi CPS LLC2022-11-23
regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit recall (Z-0309-2023)ROi CPS LLC2022-11-23
regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit recall (Z-0310-2023)ROi CPS LLC2022-11-23
regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit recall (Z-0311-2023)ROi CPS LLC2022-11-23
regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kit recall (Z-0312-2023)ROi CPS LLC2022-11-23
regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit recall (Z-0313-2023)ROi CPS LLC2022-11-23
regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience ki recall (Z-0314-2023)ROi CPS LLC2022-11-23
regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit recall (Z-0315-2023)ROi CPS LLC2022-11-23
regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit recall (Z-0316-2023)ROi CPS LLC2022-11-23
regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit recall (Z-0317-2023)ROi CPS LLC2022-11-23
regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit recall (Z-0318-2023)ROi CPS LLC2022-11-23
regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit recall (Z-0319-2023)ROi CPS LLC2022-11-23
regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit recall (Z-0320-2023)ROi CPS LLC2022-11-23
regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit recall (Z-0321-2023)ROi CPS LLC2022-11-23
regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience ki recall (Z-0322-2023)ROi CPS LLC2022-11-23
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and recall (Z-1407-2022)ROi CPS LLC2022-07-19
Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother. recall (Z-1408-2022)ROi CPS LLC2022-07-19
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile. recall (Z-1295-2022)ROi CPS LLC2022-06-28
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, recall (Z-1004-2022)ROi CPS LLC2022-04-26
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, recall (Z-1005-2022)ROi CPS LLC2022-04-26
Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Ite recall (Z-1006-2022)ROi CPS LLC2022-04-26
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, contain recall (Z-0411-2022)ROi CPS LLC2021-12-22
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and del recall (Z-0524-2021)ROi CPS LLC2020-12-02

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