23 results · 24ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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