20 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Z6 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
Oticon
FDA UDI
Oticon A/S·05707131334633·OPN 2, KIT 312 NFM 85 R C001
SA FLOWABLE ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
TRIMIRA OCS 3000
FDA 510(k)
FDA Class 2
·Dental
1823260-2015-04327
FDA Adverse Event
Malfunction
·October 14, 2015
1823260-2015-03801
FDA Adverse Event
Malfunction
·July 14, 2015
1823260-2015-03952
FDA Adverse Event
Malfunction
·August 12, 2015
DLT TS CER HD 12/14 40MM +1.5
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code LZO·June 30, 2014
TRI-LOCK BPS SZ 9 STD OFFSET
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·June 30, 2014
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 21, 2013
REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code LXH·July 5, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014
ALTRX +4 10D 40IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 30, 2014
1823260-2015-04111
FDA Adverse Event
Malfunction
·September 9, 2015
1823260-2015-03576
FDA Adverse Event
Malfunction
·June 2, 2015
1823260-2015-03948
FDA Adverse Event
Malfunction
·August 12, 2015
1823260-2016-00393
FDA Adverse Event
Malfunction
·March 31, 2016
1823260-2015-04450
FDA Adverse Event
Malfunction
·November 5, 2015
1823260-2015-03781
FDA Adverse Event
Malfunction
·July 10, 2015
1823260-2017-01826
FDA Adverse Event
Malfunction
·August 28, 2017