152 results
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19ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·March 28, 2018
CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·March 28, 2018
CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·March 28, 2018
TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·March 28, 2018
MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body.
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code NZT·November 19, 2019
12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·March 28, 2018
Access Hi-Low Exam Tables, Model 6501-XX
FDA Recall
Terminated
·Brewer Company, LLC N88·Product code LGX·March 29, 2018
Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400150A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
FDA Enforcement
Class II
·Terminated·GETINGE US SALES LLC·March 13, 2019
12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·March 28, 2018
12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·March 28, 2018
12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·March 28, 2018
12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·March 28, 2018
Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
FDA Recall
Terminated
·Childrens Medical Ventures·Product code NPF·April 29, 2014
MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body.
FDA Enforcement
Class II
·Terminated·Angiodynamics, Inc.·December 25, 2019
Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1 Product Code 708037 Product Usage: The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code IZI·January 9, 2012
MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code 708036 Product Usage: The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code IZI·January 9, 2012
Alpha-Omega Services, Inc. Product No:NFW0001-009 Description: FLEXIGUIDE NEEDLE, SERIES-15, 20 CM WITHOUT FEMALE LUER ADAPTOR, SHARP AND STYLET WITH 90-DEGREE BEND, 10/PKG Quantity: 10/PKG L-NFW0001-009. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.
FDA Recall
Terminated
·Alpha Omega Services Inc·Product code IWJ·November 15, 2007
Alpha-Omega Services, Inc. Product No: SPECIAL-NFV Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AND STYLET WITH MALE LUER 28CM, SET OF 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL- NFV. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.
FDA Recall
Terminated
·Alpha Omega Services Inc·Product code IWJ·November 15, 2007
Alpha-Omega Services, Inc. Product No:NFW0001-010 Description: FLEXIGUIDE NEEDLE, SERIES-15, 25 CM WITHOUT FEMALE LUER ADAPTOR, SHARP AND STYLET WITH 90-DEGREE BEND, 10/PKG Quantity: 10/PKG L-NFW0001-010. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.
FDA Recall
Terminated
·Alpha Omega Services Inc·Product code IWJ·November 15, 2007
Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington, DE (on carton), Paradigm Health & Wellness, Inc. (in user manuals); The products are inversion tables, which allow the user to secure his or her ankles to the table and invert. The products were intended to be fitness equipment; i.e. consumer products.
FDA Enforcement
Class II
·Terminated·Dick's Sporting Goods·January 28, 2015