25 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GEIGER NEEDLE ADAPTER, MODEL 406
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZEVO™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169329898·PLATE 3001029 ZEVO 29MM 1 LVL
ZEVO™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000663452·PLATE 3001029 ZEVO 29MM 1 LVL
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001029·artVeneer life lower anteriors, UBIS, A1
EdgePRO™
FDA UDI
US ENDODONTICS, LLC·00818365026623·EdgePRO™ Replacement Yellow Air Tube EdgePRO™ S...
XCM Biologic® Tissue Matrix
FDA UDI
DSM BIOMEDICAL, INC.·00812337020299·
Duo Lumbar Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7401001029·Duo Trial, 14mm, 8°
Citrefix 2.9mm Inserter Center Shaft
FDA UDI
Acuitive Technologies, Inc.·00810027270894·
AV1029-01 Avoset Microbore set 12222-000-1029
FDA UDI
EITAN MEDICAL LTD·17290109155972·MICROBORE INFUSION SET WITH FEMALE LUER LOCK, S...
Sapphire Connect
FDA UDI
EITAN MEDICAL LTD·17290109154302·
RANDOX C-REACTIVE PROTEIN
FDA 510(k)
FDA Class 2
·Immunology
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
FDA 510(k)
FDA Class 3
·Cardiovascular
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·February 2, 2026
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 20, 2025
URETEX SUPPORT PP TRANSOBTUR2 KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·February 28, 2013
UNKNOWN ZIMMER MIS TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·February 21, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·February 20, 2008
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code OJA·June 5, 2025
43 CM (17") APPX 2.8 ML, AMBER TRANSFER SET W/CHEMOCLAVE ADDITIVE PORT, ROTATIN
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code ONB·August 13, 2020
43 CM (17") APPX 2.8 ML, AMBER TRANSFER SET W/CHEMOCLAVE ADDITIVE PORT, ROTATIN
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code ONB·August 13, 2020