13 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RUMBLE TUFF
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OPTIFIX
FDA UDI
Davol Inc.·00801741136559·OptiFix AT Absorbable Fixation System with Arti...
Vacuum gun-adapter for P&P system
FDA UDI
Noras MRI products GmbH·04251269202254·
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK113151·DD tempMED are pre-colored dental milling blank...
AOS TIBIAL NAIL 13mm x 31.5cm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665016437·
MULTIPURPOSE DRAINAGE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 15, 2013
S3 SHOULDER PLATE 4 HOLE RIGHT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LXT·May 20, 2011
NATURAL HIP SYSTEM COLLARLESS STEM POROUS LEFT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code KWY·August 12, 2008
V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025