7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABRAHAM IRIDECTOMY LENS (YAG LASER)
FDA 510(k)
FDA Class 1
·Ophthalmic
FMS-02 FLOOR-UNIT MODEL MICROSCOPE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ADHESIVE DC ACTIVATOR
FDA 510(k)
FDA Class 2
·Dental
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 17, 2012
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 23, 2015
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026