9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FOREIGN BODY PROTECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEEDLE COUNTER-SURE COUNT/10 COUNT
FDA 510(k)
FDA Class 1
·Anesthesiology
Ingenix Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
MAXI 500
FDA Adverse Event
Injury
·ARJOHUNTLEIGH MAGOG INC.·Product code FSA·May 20, 2014
VA-LCP-2-COLUMN DRP2.4 VOLAR NARROW LE S
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·November 21, 2012
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code MTA·September 15, 2010
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·January 27, 2020
400 MICRON FIBER PROCEDURE KIT
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code GEX·April 28, 2025
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025