12 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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MUMPS IGG TEST
FDA 510(k)
FDA Class 1
·Microbiology
Gelsoft™ Cardiovascular Patch
FDA UDI
VASCUTEK LTD·05037881010694·Gelsoft Gelatin Impregnated Knitted Cardiovascu...
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471149816·K-WIRE - DOUBLE TROCAR FULLY THREADED 1.2mm DIA...
C-STEM
FDA UDI
DEPUY INTERNATIONAL LTD·10603295235613·C-STEM NECK SEGMENT SIZE 4 STD
ENDOCAM Flex HD Camera System 5521
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MASIMO SET RADICAL 7 PULSE CO-OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BEHRING FIBRINTIMER A
FDA Adverse Event
Injury
·BEHRING DIAGNOSTIC, INC.·Product code GKT·July 1, 1997
UNKNOWN T72 TIBIAL INSERT TRIAL
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·December 21, 2010
PINNACLE MTL INS NEUT40IDX60OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 14, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·July 28, 2014
FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Injury
·COOK INC·Product code EZN·May 21, 2019
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017