24 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WAVE D CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351110276·LAP-Instrument, Ø10mm, l=330mm, detach.
Grasp....
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351102189·LAP-Instrument, Ø10mm, l=330mm, flushp.
Grasp....
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351114731·LAP-Instrument, Ø10mm, l=330mm, detach.
Grasp....
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351112133·LAP-Instrument, Ø10mm, l=330mm, detach.
Grasp....
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351116971·LAP-Insert only, Ø10mm, l=330mm
Grasp....
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351104367·LAP-Instrument, Ø10mm, l=330mm, detach.
Grasp....
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351108402·LAP-Instrument, Ø10mm, l=330mm, flushp.
Grasp....
ARTEMIS
FDA 510(k)
FDA Class 2
·Radiology
CRYOCARE CS SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·October 9, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
NI
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·June 6, 2011
KIT RSV 30 TEST HOSPITAL VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 15, 2021
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DXY·February 9, 2016
MEDTRONIC LEAD
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DXY·February 9, 2016
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·September 29, 2023
CustMbite, Model Number CBT-SRS-UL
FDA Enforcement
Class II
·Ongoing·Dental Choice Holding Llc·August 10, 2022
ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·November 21, 2018