21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
Centaur Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215126919·
RONGEUR MINI FRIEDMAN-5"
FDA UDI
W.H. Holden, Inc.·D928100825450·
GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARAMIS DERMATLOGIC LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ASAHI REXEED-LX SERIES DIALYZER
FDA Adverse Event
Injury
·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·May 4, 2012
ALTRX +4 10D 32IDX52OD
FDA Adverse Event
Injury
·JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD·Product code LPH·April 29, 2013
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·April 28, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 23, 2008
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code KYB·November 20, 2017
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code KYB·November 10, 2017
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·September 17, 2020
UNFOLDER PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code KYB·August 9, 2021
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code KYB·March 24, 2016
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·April 4, 2018
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 24, 2018
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 2, 2018
CORIN METAFIX HIP STEM
FDA Adverse Event
Injury
·CORIN MEDICAL·Product code LZO·September 6, 2022
PLATINUM 1 SERIES
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code KYB·January 11, 2021
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014