25 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783
FDA 510(k)
FDA Class 2
·Hematology
NA
FDA UDI
Stryker GmbH·00886385005232·Cortical Screw, Self-tap., T6 Drive
Phantom® Fibula Nail System
FDA UDI
Paragon 28, Inc.·00889795133939·2.7mm x 22mm, Threaded Peg, Ti
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033450505·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0120220·Assembly, Screwdriver, Extended Tab
PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505
FDA 510(k)
FDA Class 2
·Cardiovascular
EXTENSION SET WITH T-CONN. SL
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·September 21, 2010
LS LF IV SET CONVRT PP W/BCCK VLV 2CLAVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·April 14, 2011
LS MICROBR EXT SET
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·August 16, 2010
EXTENSION SET WITH T-CONN. SL
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code FPA·March 15, 2012
EXTENSION SET WITH T-CONN.SL
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·January 21, 2010
EXTENSION SET WITH T-CONN. SL
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·October 14, 2011
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 22, 2013
SHUNT SENSOR SYS500
FDA Adverse Event
TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·February 28, 2011
BD PARADIGM LINK GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORPORATION·Product code NBW·March 11, 2008
RUBY COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·December 11, 2015
OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
EXTENSION SET WITH T-CONN.SL
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·January 21, 2010
LS LF IV SET CONVRT PP W/BCCK VLV 2CLAVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·March 14, 2011