11 results · 19ms · Sources: EU EUDAMED, US FDA

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SMALL BONE FIXATION SYSTEM

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450224427·

KNOTILUS+

FDA UDI
STRYKER CORPORATION·07613327627640·2.9X15.5MM KNOTILUS+ ANCHOR - PEEK

KNOTILUS+

FDA UDI
STRYKER CORPORATION·07613327627657·2.9X12.5MM KNOTILUS+ ANCHOR - PEEK

KNOTILUS+

FDA UDI
STRYKER CORPORATION·07613327627664·2.9X12.5MM KNOTILUS+ HIP ANCHOR - PEEK

PSYCHEMEDICS CANNABINOIDS EIA

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

HANDPIECE SHEATH-MODEL #A910

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ENDOTAK RELIANCE

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVY·January 11, 2013

ACCU-CHEK ® COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·December 1, 2010

XPRT MATTRESS W/O PENDANT

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code IKZ·July 3, 2014

3) Signa Advantage (K911959 Signa Advantage MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

FDA Recall
Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010