9,583 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEA 1.2 BEADCHIP KIT, SLIDE CE
FDA Adverse Event
Malfunction
·BIOARRAY SOLUTIONS LTD.·Product code PEP·December 29, 2015
DRUGS OF ABUSE POSITIVE
FDA UDI
UTAK LABORATORIES, INC.·B800DAUPOSFKBI0·DRUGS OF ABUSE POSITIVE
PIC-50
FDA Adverse Event
Malfunction
·MRL, INC. A WELCH ALLYN COMPANY·Product code MKJ·June 12, 2006
INTERGARDAORTIC ARCH WOVEN VASCULAR PROSTHESIS
FDA Adverse Event
Malfunction
·INTERVASCULAR·Product code DSY·November 16, 2005
KBIO® Dura
FDA UDI
COLLAGEN MATRIX, INC.·00813954023823·Dural Repair Collagen Matrix 125 x 175 125 x 1...
KBIO® Dura
FDA UDI
COLLAGEN MATRIX, INC.·00813954023779·Dural Repair Collagen Matrix 25 x 25 25 x 25mm...
KBIO® Dura
FDA UDI
COLLAGEN MATRIX, INC.·00813954023816·Dural Repair Collagen Matrix 100 x 125 100 x 1...
KBIO® Dura
FDA UDI
COLLAGEN MATRIX, INC.·00813954023786·Dural Repair Collagen Matrix 25 x 75 25 x 75mm...
KBIO® Dura
FDA UDI
COLLAGEN MATRIX, INC.·00813954023793·Dural Repair Collagen Matrix 50 x 50 50 x 50mm...
KBIO® Dura
FDA UDI
COLLAGEN MATRIX, INC.·00813954023809·Dural Repair Collagen Matrix 75 x 75 75 x 75mm...
NEOBLUE
FDA Adverse Event
Malfunction
·NATUS MEDICAL INCORPORATED·Product code LBI·September 26, 2017
NEOBLUE
FDA Adverse Event
Malfunction
·NATUS MEDICAL INCORPORATED·Product code LBI·September 26, 2017
DRUGS OF ABUSE POSITIVE
FDA UDI
UTAK LABORATORIES, INC.·B800DAPOSV2WBFKBI0·DRUGS OF ABUSE POSITIVE
SYNCHRON LX I 725 CLINICAL SYSTEM
FDA Adverse Event
Other
·BECKMAN COULTER, INC.·Product code JJE·June 17, 2005
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC·Product code GJS·August 13, 2014
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·December 18, 2018
ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II
FDA Adverse Event
Malfunction
·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·April 2, 2012
ASAHI SION BLUE
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·August 25, 2024
TECNIS IOL
FDA Adverse Event
Injury
·AMO MANUFACTURING NETHERLANDS·Product code MFK·August 15, 2022
ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and Address on Label: CooperVision Hamble, SO31 4RF, UK, and Scottsville, NY 14546 USA --- Each lens is supplied sterile in a blister containing buffered saline solution. The blister is labeled with the base curve, diameter, dioptric power, manufacturing lot number, and expiration date of the lens. ClearSight contact lenses are made from a material containing 55% water and 45% ocufilcon D, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling. When placed on the cornea in its hydrated state, the ClearSight" (ocufilcon D) Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.
FDA Recall
Terminated
·CooperVision Inc.·Product code MVN·August 28, 2009