14 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REPROCESSED HARMONIC SCALPEL
FDA 510(k)
FDA Unclassified
·Unknown
Bernafon
FDA UDI
Bernafon AG·05711584005590·CT9 M, VC PS SF MAC CANTEO 9
ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
XLTEK LED GOGGLES, MODEL LED-01
FDA 510(k)
FDA Class 2
·Neurology
GLEN RESURFACING REAMER D27 MM
FDA Adverse Event
Malfunction
·DEPUY FRANCE SAS 3003895575·Product code LXH·July 28, 2015
MODULAR ECC EPI TRIAL SZ2 LEFT
FDA Adverse Event
Malfunction
·DEPUY FRANCE SAS 3003895575·Product code LXH·July 28, 2015
UNKNOWN MEDTRONIC ADVANCED ENERGY DEVICE
FDA Adverse Event
Injury
·MEDTRONIC ADVANCED ENERGY·Product code GEI·August 10, 2012
BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·January 16, 2024
TRANSVENE
FDA Adverse Event
Injury
·.·Product code LWS·May 14, 2013
ALARIS PUMP MODULE
FDA Adverse Event
Injury
·CAREFUSION CORP·Product code FRN·May 25, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·August 14, 2008
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
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