9 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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AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
Sklar®
FDA UDI
SKLAR CORPORATION·10649111135873·BAINBRIDGE FCP CVD 7 1/4" SERR
SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE
FDA 510(k)
FDA Class 2
·Cardiovascular
CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SORIN C5 SYSTEM WITH MAST ROLLER PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DWB·May 21, 2012
ACTIFUSE BONE GRAFT SUBSTITUTE
FDA Adverse Event
Injury
·BAXTER APATECH LTD·Product code MQV·June 17, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 24, 2011
GMK SPHERE TIBIAL TRAY SIZE T3I4 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 25, 2014
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017