9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARGENCO Y +
FDA 510(k)
FDA Class 2
·Dental
N/A
FDA UDI
Karl Storz GmbH & Co. KG·04048551446690·
CANDELA DIODE TRABECULOPLASTY LASER DTL
FDA 510(k)
FDA Class 2
·Ophthalmic
VENTREX COATED TUBE IGE RADIOIMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
HEARTMATE II SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORP.·Product code DSQ·June 11, 2014
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LZO·January 10, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 1, 2010
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·September 27, 2023
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code EOQ·July 7, 2023