48 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code HRH·May 3, 2013
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
FDA Recall
Terminated
·ROi CPS LLC·Product code OEZ·May 20, 2022
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
EVIS EXERA III Bronchovideoscope
FDA Recall
Terminated
·Aizu Olympus Co., Ltd. 1 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·July 20, 2022
progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.
FDA Recall
Terminated
·ProgenaCare·Product code KGN·April 18, 2022
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall.
FDA Recall
Terminated
·Abiomed, Inc.·Product code DTZ·December 14, 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
regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJK·October 20, 2022
regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJG·October 20, 2022
regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJH·October 20, 2022
regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJG·October 20, 2022
regard CVPART1BUNDLE- MERCYSTANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OEZ·October 20, 2022
regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJG·October 20, 2022
regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJK·October 20, 2022
regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJG·October 20, 2022
regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit
FDA Recall
Terminated
·ROi CPS LLC·Product code OJG·October 20, 2022