72 results
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30ms
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Sources: EU EUDAMED, US FDA
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
FDA Recall
Terminated
·ROi CPS LLC·Product code MLS·October 12, 2020
Isolation Droplet Bundle Kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OEA·May 19, 2020
Respirator Crash Cart Kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OEV·May 19, 2020
REGARD Vitrectomy Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code OJK·August 10, 2021
REGARD Core Biopsy Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code LRO·August 10, 2021
REGARD Ear Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code OGR·August 10, 2021
REGARD Basic Cataract tray
FDA Recall
Terminated
·ROi CPS LLC·Product code OJK·August 10, 2021
REGARD Stereotactic Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code OIP·August 10, 2021
REGARD Newborn Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code MLS·August 10, 2021
REGARD Ultrasound Tray
FDA Recall
Terminated
·ROi CPS LLC·Product code OIP·August 10, 2021
Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
FDA Recall
Terminated
·ROi CPS LLC·Product code FTN·April 20, 2020
Regard, T AND A - Rogers, sterilized convenience kits
FDA Recall
Terminated
·ROi CPS LLC·Product code OGR·November 30, 2021
regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJK·October 20, 2022
regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJH·October 20, 2022
regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJG·October 20, 2022
regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJG·October 20, 2022
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, Item 800070009, Lot # 82442. 4) Regard, NEURO, Item 800040011, Lot # 82504. 5) Regard, LAP CHOLE, Item 800003011, Lot # 82497. 6) Regard, SHOULDER ARTHRO, Item 800075010, Lot # 82490. 7) Regard, CERVICAL, Item 800058007, Lot # 82592. 8) Regard, ARTHROSCOPY, Item 800027008, Lot # 82582. 9) Regard, MAJOR SURGERY, Item 800013010, Lot # 82844. 10) Regard, GENERAL SURGERY, Item 800057012, Lot # 82832. 11) Regard, SEPTO SINUS ENDO, Item 800024006, Lot # 82876. 12) Regard, MINOR FMOL-LADY OF THE LAKE, Item 800019009, Lot # 82893. 13) Regard, KNEE ARTHRO, Item 800072009, Lot # 83058. 14) Regard, LAP, Item 800096005, Lot # 83139. 15) Regard, KNEE ARTHROSCOPY, Item 800121, Lot # 83251. 16) Regard, CYSTOSCOPY, Item 800093007, Lot # 83138. 17) Regard, LAP CHOLE, Item 800035007, Lot # 83257. 18) Regard, PERIPHERAL VASCULAR, Item 800007011, Lot # 83106. 19) Regard, PACEMAKER, Item 800083006, Lot # 82886. 20) Regard, I&D, Item 800056005, Lot # 83135. 21) Regard, HEAD & NECK, Item 800068010, Lot # 83050. 22) Regard, ROBOTICS, Item 800103007, Lot # 83264. 23) Regard, MAJOR EAR, Item 800070010, Lot # 82879. 24) Regard, ORTHO EXTREMITY, Item 800042009, Lot # 83383. 25) Regard, CRANIOTOMY, Item 800025015, Lot # 83271. 26) Regard, MINOR ORTHO, Item 800020007, Lot # 83583. 27) Regard, VATS, Item 800118001, Lot # 83421. 28) Regard, ARTHROSCOPY, Item 800027008, Lot # 83560. 29) Regard, OPEN HEART, Item 800023010, Lot # 83273. 30) Regard, PERIPHERAL VASCULAR, Item 800018011, Lot # 83575. 31) Regard, GENERAL PROCEDURE, Item 800000008, Lot # 83576. 32) Regard, DR WHITE OPEN HRT A&B, Item 800045012, Lot # 82847. 33) Regard, NEURO, Item 800008008, Lot # 83598. 34) Regard, LAPAROSCOPY, Item 880320008, Lot # 82472. 35) Regard, PACEMAKER, Item 880074023, Lot # 82417. 36) Regard, THYROID, Item 880425002, Lot # 82389. 37) Regard, LAPAROSCOPY, Item 880350012, Lot # 82473. 38) Regard, CHEST, Item 880373005, Lot # 82427. 39) Regard, BASIC CATARACT, Item 880348006, Lot # 82501. 40) Regard, CCOR HAND, Item 880337009, Lot # 82496. 41) Regard, CRANIOTOMY, Item 880396004, Lot # 82507. 42) Regard, TUR CYSTO, Item 880357006, Lot # 82574. 43) Regard, TOTAL HIP, Item 880266, Lot # 82478. 44) Regard, DAVINCI, Item 880132021, Lot # 82469. 45) Regard, KNEE ARTHROSCOPY, Item 880368, Lot # 82485. 46) Regard, UROLOGY, Item 880306010, Lot # 82584. 47) Regard, MINOR BREAST, Item 880195017, Lot # 82588. 48) Regard, LABOR & DELIVERY, Item 880081018, Lot # 82600. 49) Regard, PELVIC PROCEDURE, Item 880214016, Lot # 82597. 50) Regard, CCOR MINOR, Item 880336010, Lot # 82593. 51) Regard, YOUNG LUMBAR, Item 880432005, Lot # 82594. 52) Regard, PACEMAKER, Item 880418003, Lot # 82606. 53) Regard, LOCAL, Item 880087014, Lot # 82828. 54) Regard, COLON LITHOTOMY, Item 880395002, Lot # 82825. 55) Regard, EYE, Item 880099029, Lot # 82882. 56) Regard, FESS, Item 880404001, Lot # 83033. 57) Regard, CYSTO, Item 880312009, Lot # 82880. 58) Regard, EXTREMITY PACK, Item 880167018, Lot # 82887. 59) Regard, PHERIPHERAL VASC, Item 880077, Lot # 83048. 60) Regard, T & A, Item 880423002, Lot # 83073. 61) Regard, C CABG A & B, Item 880080, Lot # 83042. 62) Regard, DR MARBARGER, Item 880079011, Lot # 83124. 63) Regard, MPR LOCAL, Item 880360006, Lot # 83133. 64) Regard, KNEE ARTHROSCOPY, Item 880268, Lot # 83095. 65) Regard, MINOR PROCEDURE, Item 880261009, Lot # 83132. 66) Regard, EXTREMITY, Item 880262009, Lot # 83071. 67) Regard, LAPAROSCOPY, Item 880102018, Lot # 83238. 68) Regard, GENERAL LAPAROSCOPY, Item 880405002, Lot # 83254. 69) Regard, MAJOR PROCEDURE, Item 880270008, Lot # 83240. 70) Regard, YOUNG LUMBAR, Item 880432005, Lot # 83232. 71) Regard, MINOR LITHOTOMY, Item 88
FDA Recall
Terminated
·ROi CPS LLC·Product code EFQ·November 9, 2020
Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
FDA Recall
Terminated
·ROi CPS LLC·Product code MLS·June 14, 2021
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
FDA Recall
Terminated
·ROi CPS LLC·Product code MLS·June 14, 2021
regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJK·October 20, 2022