11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DeBakey-Castaneda Clamp, 12cm, slightly curved shanks
FDA UDI
Geister Medizintechnik GmbH·04057034057780·DeBakey-Castaneda Clamp, 12cm,
slight...
CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
FDA 510(k)
FDA Class 2
·Cardiovascular
WET CHAMBER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
PROFEMUR(R) MODULAR FEMORAL NECK
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·August 23, 2011
PRE-FILLED NORMAL SALINE FILLED FLUSH
FDA Adverse Event
Malfunction
·BD MEDICAL SYSTEMS·Product code FMF·June 28, 2013
SCREW
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HWC·November 3, 2014
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025