29 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634
FDA 510(k)
FDA Class 2
·Hematology
PALACOS®
FDA UDI
Heraeus Medical GmbH·04260102136120·The PALACOS® R pro system consists of a mixing ...
POWDER-FREE NITRILE EXAM GLOVE, BLUE
FDA 510(k)
FDA Class 1
·General Hospital
ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10
FDA 510(k)
FDA Class 2
·Clinical Toxicology
2027971-2026-081286
FDA Adverse Event
Injury
·NOBEL BIOCARE USA, LLC·Product code DZE·May 20, 2026
SAFIL VIOLET 8/0 (0.4) 30CM 2XDLM6
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·August 9, 2019
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·April 26, 2013
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·September 11, 2014
STEALTHSTATION TRIA NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 21, 2011
SAFIL VIOLET 1 (4) 90CM HR48 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·November 20, 2019
Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
FDA Enforcement
Class II
·Ongoing·Heraeus Medical GmbH (Dental Division)·January 21, 2026
SAFIL UNDYED 4/0 (1,5) 45CM DS19 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·July 5, 2019
SILKAM BLACK 2/0 (3) 10X45CM
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAP·October 7, 2019
SAFIL VIOLET 2/0 (3) 70CM HR40S (M)
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.U.·Product code GAM·September 9, 2021
SAFIL VIOLET 5/0 (1) 45CM DS12 (M)
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·August 24, 2021
SAFIL VIOLET 3/0 (2) 70CM HR30 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·June 24, 2019
SAFIL VIOLET 2/0 (3) 70CM DS24 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·June 24, 2019
SAFIL VIOLET 0 (3.5) 5X70CM
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·January 29, 2020
SAFIL C VIOLET 2 (5) 15M
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·March 11, 2020
SAFIL VIOLET 0(3,5)8X45CM HR40S TO(M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·August 6, 2019