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