23 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RANDOX AMMONIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Pratt Dilator Extra Large
FDA UDI
MEDGYN PRODUCTS, INC.·M803030873·Pratt Dilator Extra Large 53-55 Fr (17.6-18.3 mm)
VERMED A10021 RESTING EKG TAB ELECTRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
MENTOR SELF-CATH CLOSED SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
2027971-2025-030873
FDA Adverse Event
Injury
·NOBEL BIOCARE USA, LLC·Product code DZE·January 10, 2025
21GX.75IN. BD VACUTAINER® WINGED SAFETY PBBCS WITH 12 IN TUBING
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code JKA·November 27, 2017
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET PRE-ATTACHED HOLDER 23G NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 3, 2017
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·January 31, 2024
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS·Product code LYJ·April 2, 2013
ICEMAN THERAPY UNIT
FDA Adverse Event
Injury
·DJ ORTHOPEDICS DE MEXICO·Product code ILO·March 21, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·April 3, 2024
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FPA·February 28, 2024
8) Signa 3.0T Infinity with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) Signa 3.0T with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) The GE Signa@ Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa@ Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa@ Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·November 9, 2010
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FPA·January 18, 2024
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FPA·December 14, 2023
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·February 7, 2024
ALLOCLASSIC VARIALL, SLV STEM, UNCEMENTED, 2, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·March 29, 2018
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·November 21, 2023
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·January 31, 2024