23 results · 21ms · Sources: EU EUDAMED, US FDA

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ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE

FDA 510(k)
FDA Class 3 ·Cardiovascular

CystoFlex™ UHD R-C

FDA UDI
MAUNA KEA TECHNOLOGIES·03760187910253·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450641934·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450160107·

5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM

FDA Adverse Event
Injury ·SYNTHES MEZZOVICO·Product code JDP·August 28, 2015

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K1100540·Caddie, 8.5mm Screws

MYSTIQUE® MB

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110151101·MYSTIQUE® MB RT RX 018 U 5-5 CS HK

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·January 26, 2015

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·March 2, 2015

IMPLANT, FIXATION DEVICE CONDYLAR PLATE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code JDP·February 23, 2017

FIXCET SPINAL FACET SCREW SYSTEM

FDA 510(k)
FDA Unclassified ·Unknown

CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L

FDA 510(k)
FDA Class 2 ·Anesthesiology

VARISOFT

FDA Adverse Event
Malfunction ·Product code FPA·March 6, 2023

IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code JDP·June 1, 2015

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE·Product code ITI·May 13, 2013

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 23, 2014

LINK(R) MP(TM) NECK

FDA Adverse Event
Injury ·WALDEMAR LINK GMBH & CO. KG·Product code JDI·June 1, 2011

OT VERIO2 METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 26, 2014

4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT

FDA Adverse Event
Injury ·SYNTHES MEZZOVICO·Product code HRS·July 24, 2015

Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction. This MRI system is indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities. Image appearance is determined by the spatial distribution and flow as well as by many different NMR related properties of the tissue and anatomy studied and the MRI scan technique applied. These images and/or spectra, when interpreted by a trained physician, provide information that may assist the diagnosis.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LNH·August 3, 2011