42 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902
FDA 510(k)
FDA Class 2
·Cardiovascular
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001021·artVeneer life lower anteriors, UCM, A1
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950030279·SCISSOR IRIS VERY DELICATE STRAIGHT 4" 10CM
MPS Back Up System, front crank
FDA UDI
QUEST MEDICAL INC·20634624510214·MPS Back Up System, front crank, blood only
ZEVO™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169329850·PLATE 3001021 ZEVO 21MM 1 LVL
ZEVO™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000663414·PLATE 3001021 ZEVO 21MM 1 LVL
Sinton Medical Products
FDA UDI
Shenzhen Boon Medical Supply Co., Ltd.·06938327900168·60"(1500mm) Y Coiled Tubing with Dual Check Valves
XCM Biologic® Tissue Matrix
FDA UDI
DSM BIOMEDICAL, INC.·00812337020213·
SpectraVue
FDA UDI
Shenzhen Boon Medical Supply Co., Ltd.·06938327901639·1-60"(1500mm) Y Coiled Tubing with Dual Check V...
Sinton Medical Products
FDA UDI
Shenzhen Boon Medical Supply Co., Ltd.·06938327902612·1- 60"(1500mm) Y Coiled Tubing with Dual Check ...
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540245793·POINTER, LEFT POSTERIOR-FOSSA
AESCULAP BONE WAX
FDA 510(k)
FDA Unclassified
·Unknown
IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB
FDA 510(k)
FDA Class 2
·Immunology
ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032
FDA 510(k)
FDA Class 2
·Radiology
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013
UNKNOWN ZIMMER MIS TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·February 21, 2011
LINEAGE TRANSCEND CERAMIC ACETABULAR LINER
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code MRA·February 20, 2008
BONE WAX 24X2.5G
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MTJ·October 30, 2019
CustMbite, Model Number CBT-SRS-UL
FDA Enforcement
Class II
·Ongoing·Dental Choice Holding Llc·August 10, 2022
TAPERLOC POR FMRL 15X150
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·February 13, 2020