8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAGNETIC RESONANCE DEVICE ACCESSORY (MRT-50A)
FDA 510(k)
FDA Class 2
·Radiology
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909114952·REVELATION DIAMOND SE3-010VF - 5 PACK
ARTHREX BIO-POST AND WASHER
FDA 510(k)
FDA Class 2
·Orthopedic
COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STAPLE, IMPLANTABLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 14, 2015
NEXUS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 11, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 2014
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