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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 10 Results
510(K) Number: K011811
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Product Description
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FDA Recall
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Monarch Inflation Device and Fluid Dispensing Syringe - Latex Free MERIT MEDICAL. Sterile if pack... 2 11/19/2003 Merit Medical Systems, Inc
KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A. Kyphon Catalog Numb... 2 07/20/2004 Kyphon Inc
Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog ... 2 09/09/2011 Medtronic Spine LLC (formerly Kyphon Inc.)
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B 2 10/11/2024 Merit Medical Systems, Inc.
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Infl... 2 10/11/2024 Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion To... 2 10/11/2024 Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device R... 2 10/11/2024 Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device... 2 10/11/2024 Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Ballo... 2 10/11/2024 Merit Medical Systems, Inc.
Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque De... 2 10/11/2024 Merit Medical Systems, Inc.
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