221 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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AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.
FDA Recall
Terminated
·Neuro Kinetics, Inc.·Product code GWN·November 21, 2013
Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GWN·July 9, 2014
I-Portal NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of central vs. peripheral nervous system deficits.
FDA Recall
Terminated
·Neuro Kinetics, Inc.·Product code GWN·April 30, 2015
Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.
FDA Recall
Terminated
·Neuro Kinetics, Inc.·Product code GWN·July 21, 2015
Straumann Impression set for WN solid abutment H 4.00mm POM/ AI. Ref : 040.380 Kit Y4021. Intended to aid in the fabrication of dental prosthetics, and be used as a accessory with endosseous dental implants.
FDA Recall
Terminated
·Straumann Manufacturing Inc.·Product code NDP·June 15, 2010
GEN*S SlideMaker, Barcode Label Specifications, GEN*S SM Intended Use, GEN*S Slide and Sample, Part Numbers 6605360, P/N 4237221, 4237212, and 4277299. Intended for use as an optional peripheral to the COULTER GEN*S System. Creates a blood smear on a clean microscope slide using a segment of the blood sample aspirated by the GEN*S System.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code KPA·May 29, 2008