27 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032710·Baltic Denture System BDLoad Mw7 PLSEbim6DFm BL...
Cook
FDA UDI
COOK INCORPORATED·00827002170780·Silicone Universal Drainage Stent
Plateau-LO Spacer System
FDA UDI
Life Spine, Inc.·00190837027605·PLATEAU-LO Interbody, 10mm x 32mm x 10mm, 7°
Trulink
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522101809·LDWR,SET,DIN,PINCH,5-LEAD,61CM/24IN,IEC,1/ST
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180501160·SHARP COBB, STRAIGHT 12MM
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180501214·SHARP COBB, STRAIGHT 22MM
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180501184·SHARP COBB, STRAIGHT 18MM
DISPOSABLE POWDERED VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION)
FDA 510(k)
FDA Class 2
·Orthopedic
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·December 18, 2009
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·May 17, 2010
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·December 18, 2009
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·November 17, 2009
AVALUS AORTIC TISSUE VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 23, 2020
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·April 3, 2013
PHYSIOMESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·March 17, 2011
ACCU-CHEK MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·April 22, 2008
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·May 25, 2010
Ortho Kit, Kit number PSS1039(A and PSS1039(B convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016